NIAIC

Medical Device and Equipment Alerts MDEA Updates - 2010

Number	Issue Date	Level Of Urgency	Title
MDA/2010/098	20 Dec 2010	Immediate	Defibrillator monitor: PIC 50 manufactured by Welch Allyn, serviced under contract by Zoll UK. Failure of the display screen, which prevents viewing of ECG and other vital signs. Risk of delay or failure to administer defibrillation. (PDF 29 KB)
MDA/2010/097	20 Dec 2010	Immediate	X-ray detectable gauze swabs manufactured by Rocialle. Specific batch numbers.Rocialle is recalling specific batch numbers of X-ray detectable gauze swabs. Risk of tapes becoming detached in use. Risk of incorrect number of swabs in a tied pack of five. (PDF 36 KB)
MDA/2010/096	16 Dec 2010	Action	Paediatric tracheostomy tubes. All Shiley paediatric models and sizes manufactured by Covidien (formerly Tyco Healthcare).The MHRA is aware of an increase in failure rate of paediatric Shiley tracheostomy tubes, based on reports received between 2008 and 2010. In some instances, it may be difficult to pass the obturator or suction catheter into the Shiley tracheostomy tubes. The devices are not being recalled by the manufacturer as Covidien considers the failure rate to be relatively low. However, the MHRA is urging that Shiley tracheostomy tubes be used with caution. (PDF 19 KB)
MDA/2010/095	16 Dec 2010	Immediate	Implantable cardioverter defibrillator (ICD) leads. Riata and Riata ST – all models. Manufactured by St Jude Medical. Risk of inappropriate therapy due to wear and/or abrasion of lead insulation. (PDF 19 KB)
MDA/2010/094	14 Dec 2010	Action	Umbilical cord clamp. All makes and models. Incorrect placement of the clamp on the umbilical cord has lead to an inadequate seal and blood loss in a small number of cases. Such blood loss could prove fatal for some babies. (PDF 284 KB)
EFA/2010/012	13 Dec 2010	Action	Toffeln Qwirki’s 800 Crocs Style Clogs sold as personal protective equipment (PPE).Toffeln Qwirki’s 800 Crocs Style Clogs sold as Personal Protective Equipment (PPE) may not provide protection against penetration by sharp objects through the sole. (PDF 69 KB)
MDA/2010/093	1 Dec 2010	Action	Contact lenses. 1 Day Acuvue TruEye (narafilicon A). Manufactured by Johnson & Johnson Vision Care (Ireland). Lot numbers with the first six digits within the ranges 492237 to 492498 inclusive and 502080 to 502269 inclusive. Recall of specific product. Lenses from affected lots can cause stinging or pain upon insertion because of higher than expected levels of decanoic acid.(PDF 24 KB)
MDA/2010/092	30 Nov 2010	Action	All Oxylog 3000 emergency/transport ventilators. Manufactured by Draeger. Insufficient ventilation of paediatric patients when using small tidal volumes (50 -100 ml). This problem can result in gas being re-breathed and a potential dangerous rise in CO2.(PDF 47 KB
MDA/2010/091	30 Nov 2010	Action	Linear accelerator C-Series Clinacs manufactured by Varian Medical Systems Inc. Models H14, H18, H29. The collimator cover can become loose and fall on to the patient during treatment. It is possible to install the cover incorrectly, but still fasten the latching mechanism; this leaves the potential for the cover to fall off.(PDF 30 KB)
EFA/2010/011	24 Nov 2010	Action	Self-harm associated with wardrobes (PDF 40 KB)
MDA/2010/090	24 Nov 2010	Action	Patient vital signs monitor. Models M3002 IntelliVue X2 and M8102A IntelliVue MP2 manufactured by Philips Healthcare. Affected serial numbers X2: DE83629383—DE95052110 inclusive MP2: DE83604981—DE95008299 inclusive. The loud speakers on Philips IntelliVue X2 and MP2 monitors can fail. This may delay the recognition of critical clinical signs, delaying the patient’s treatment.(PDF 130 KB)
MDA/2010089	19 Nov 2010	Immediate Action	Level 1® normothermic IV fluid administration sets for use with fast flow fluid warming units manufactured by Smiths Medical. Product codes D-60HL and DI-60HL. Specific lots. This disposable IV fluid administration set has a heat exchanger assembly that may be too long. The set may not fit into Level 1® fast flow fluid warmers making the set unusable. This could delay treatment while another disposable set or an alternative method of fluid warming is obtained. (PDF 24 KB)
MDA/2010/088	17 Nov 2010	Action	Uterine sounds. Manufactured by Rocket Medical plc. Model number R57420, lot 416163. Model number R60547, lots 416367 and 416818. Incorrect moulding of uterine sound stem has resulted in a shorter length device. The uterine sound will not function correctly with a missing distal tip and the condition of the stem could cause injury.(42 KB)
MDA/2010/087	4 Nov 2010	Action	Siemens e.cam gamma camera. The MHRA is aware of an incident in which a patient was injured (finger amputation) during movement of the gamma camera couch (patient handling system).(PDF 22KB)
MDA/2010/086	03 Nov 2010	Action	All XLT manual wheelchairs with a backrest height of less than 40cm. Manufactured by Invacare. XLT wheelchairs with a backrest height of less than 40cm are not suitable for use as a seat in a vehicle. Occupants will be at increased risk of injury in the event of a vehicle impact. Invacare has issued a Field Safety Notice (FSN031) with warning labels to be affixed to each wheelchair but have been unable to trace all users.(PDF 41KB)
MDA/2010/085	28 Oct 2010	Action	All Oxford Midi 150A electrical hoists manufactured by Sunrise Medical before December 2005. There is the potential for the hoist to fail during lifting resulting in serious injury to the occupant or others.(PDF 72KB)
MDA/2010/084	27 Oct 2010	Action	Disposable coring bone trephine and disposable dowel harvest tube. Manufactured by Biomet Sports Medical. The manufacturer is recalling specific lots of disposable coring trephine and dowel harvesting tubes used for autogenous bone procedures. These devices are fitted with end caps that may leave a residue on the instruments or discolour them. Currently, it is not known if this residue will have any adverse effect on patients. This is being investigated and further information will be provided if appropriate. (PDF 41KB)
MDA/2010/083	25 Oct 2010	Action	Specific models and serial numbers of Contoura 800 series beds manufactured by Huntleigh Healthcare Ltd. The manual operating system for the emergency cardiopulmonary resuscitation (CPR) function might fail. ArjoHuntleigh has issued a Field Safety Notice detailing the specific areas to be examined, but has been unable to trace all affected beds. (PDF 97KB)
MDA/2010/082	20 Oct 2010	Action	Haemodialysis bloodlines: 5008/5008S, 4008 E-beam and 4008 ETO Manufactured by Fresenius Medical Care AG & Co KGaA. Specific product codes.Due to a change in material used in the manufacture of Fresenius Medical Care bloodline connectors, it may be difficult to connect them to other manufacturers’ dialysers. There is an increased risk of haemolysis and blood leakage occurring. (PDF 32KB)
EFA/2010/010	19 Oct 2010	Action	Automated thermal washer disinfectors with independent monitoring. There is a risk of infection if surgical instruments are processed in a faulty or incorrectly set up automated thermal washer disinfector with inadequate or disabled independent monitoring. (PDF 38KB)
EFA/2010/009	19 Oct 2010	Immediate	Flush fitting anti-ligature curtain rails: ensuring correct installation.(PDF 28KB)
MDA/2010/081	14 Oct 2010	Action	Ambulance trolley. Model 6100 M1 manufactured by Stryker. Affected serial numbers: 001239066 – 091139098 inclusive. Components of the head end of the trolley can break during use which may cause the head end to collapse. This has the potential to injure patients and staff and/or delay treatment of the patient (PDF 199KB)
MDA/2010/080	12 Oct 2010	Action	Atlantic bed rails. Product code EBA013. Manufactured by Park House Healthcare Ltd.The original instructions for use issued with these bed rails contained insufficient information for correct installation. If incorrectly fitted there is a risk of entrapment between the bed rail and the head or foot board of the bed, resulting in postural asphyxiation. Park House Healthcare has issued a Field Safety Notice, but is unable to trace all bed rails. (PDF 56 KB)
MDA/2010/079	11 Oct 2010	Immediate	Smart Chargers for Neptune, Aquila and Splash bath lifts and for Mountway Solo toilet lifts. The three-pin mains plugs fitted to some of these smart battery chargers do not meet the requirements of BS 1363-1 in body, pin and fuse construction and are potentially unsafe. Mountway issued a Field Safety Notice in September 2010 but cannot trace all users. (PDF 77 KB)
MDA/2010/078	04 Oct 2010	Immediate	Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All devices implanted after 01 January 2001. Clinical management of women implanted with PIP silicone gel filled implants (PDF 23KB) Please note further advice is given in MDA/2012/011
MDA/2010/077	04 Oct 2010	Action	Contact lenses. Softperm (synergicon A) daily wear. Manufactured by Ciba Vision Corporation. Recall of specific product. Product may cause eye infections and/or burning and stinging upon initial insertion of the lens. ( PDF 35KB
MDA/2010/076	29 Sep 2010	Action	SleepStyle CPAP devices. Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers are affected. Risk of cessation of therapy due to deterioration of power cord. (PDF 19KB)
MDA/2010/075	28 Sep 2010	Action	All Ventnor mobile shower chairs manufactured by James Spencer & Co Ltd. Due to inadequate maintenance instructions, castors may loosen and detach, causing the user to fall from the chair. (PDF 43KB)
MDA/2010/074	21 Sep 2010	Action	Patient vital signs monitor: Delta and Gamma XXL manufactured by Draeger Medical. The keypad can become inoperative or activate unintentionally, which may result in a treatment delay. Affected units were manufactured from March 2008 to April 2009 inclusive. (PDF 67KB)
MDA/2010/073	20 Sep 2010	Action	Intravenous (IV) extension sets with multiple ports: all brands. Risk of back-tracking when an IV line has multiple access ports. This can lead to under-infusion or bolus delivery of IV drugs.(PDF 68KB)
MDA/2010/072	16 Sep 2010	Immediate Action	Vascular catheters: K-Flow Access Catheters. Kimal High Flow (HF) Haemodialysis Catheters. Kimal Right Atrial (KRA) Catheters. Manufactured by Kimal. Devices with specific product codes and expiry dates are affected. The CE marking of these specific catheters is invalid. The safety and performance of these devices has not been submitted for independent assessment. (PDF 23KB)
MDA/2010/071	13 Sep 2010	Action	Tracheostomy dressing. Manufactured by Kapitex Healthcare Ltd. Trachi-Dress TR DRE 0001. Lots: WO 25700 – WO 25702. Supplied in the UK from 28/07/09 to 11/01/10. The dressing material may have poor lamination, primarily on the shiny side (patient contact side). It may de-laminate in use over time with the possibility of viscose fibres detaching and entering the tracheal stoma. This is described in the manufacturer’s Field Safety Notice FSN 001 Rev 1. (PDF 37KB)
MDA/2010/070	09 Sep 2010	Action	LIFEPAK 20/20e defibrillator/monitor. Manufactured by Medtronic/Physio-Control. Specific serial numbers are affected. Due to component failures, which affect AC (mains) and/or DC (battery) operating power, there is a risk that the defibrillator will not deliver therapy. The corrective action programme initiated by the manufacturer will take approximately two years to complete. (PDF 36KB)
MDA/2010/069	07 Sep 2010	Immediate Action/Update	This Alert has been replaced by MDA-2012-036’.
MDA/2010/068	06 Sep 2010	Immediate	IV extension sets with multiple ports and vented caps. Various manufacturers. Risk of air embolism and death. (PDF 33KB)
MDA/2010/067	26 Aug 2010	Action	Contact lens solution. AMO Complete® multi-purpose solution. Manufactured by Abbott Medical Optics Inc (AMO). Recall of specific product lot numbers. Sterility of the product may be compromised due to poor fitting caps. (PDF 75KB)
MDA/2010/066	19 Aug 2010	Immediate	Neurosurgical sponges (patties). Manufactured by Codman. Product code: 80-1396 and 80-1399. Specific lots (see manufacturer’s Field Safety Notice). Radiopaque strips may be retained in patients. Codman is recalling surgical sponges (patties) from certain lots (distributed from May 2009 to May 2010 inclusive) because affected products were manufactured with reduced adhesion between the sponges and the blue radiopaque strip. This may result in the strip becoming detached during surgery. (PDF 131KB)
MDA/2010/065	16 Aug 2010	Immediate	Suction liners. Receptal 1, 1.5 and 2 litre PVC liners. Manufactured by Hospira (formerly manufactured by Abbott). Due to a manufacturing fault, the lid of Receptal PVC suction liners may not be correctly aligned. When fitted to the suction canister this can result in an inadequate seal and loss of suction. To date, up to 10% of the affected suction liners have exhibited misaligned lids. (PDF 53KB)
MDA/2010/064	11 Aug 2010	Immediate Action	Novabel® dermal filler. Manufactured by Merz Pharmaceuticals GmbH. 1x1 ml, Art.-Nr. 40800 and 2x1ml, Art.-Nr. 49021. All batches. Use of Novabel® dermal filler may cause adverse reactions.(PDF 24KB)
MDA/2010/063	05 Aug 2010	Immediate Action	T-Bag oxygen enrichment device: 7000T. Manufactured by Ultimate Medical Pty Ltd. Distributed in the UK by Intavent Direct. All devices supplied prior to February 2010 are affected. NHS Supply Chain code: FDE376. Possible occlusion of T-Bag oxygen enrichment device by a plastic membrane which is caused by a moulding fault during manufacture. This fault could prevent or restrict the gas flow to the patient. (PDF 44 KB)
MDA/2010/062	2 Aug 2010	Action	Processing AT1 set (item no. 9005101) used with the CATS® continuous autotransfusion system. Manufactured by Fresenius Kabi. Sets manufactured between January 2009 and April 2010 are affected. A manufacturing problem has been identified with these sets which can result in failure to prime. This may then require a manual intervention to allow the process to continue. This can cause interruption to therapy (PDF 24KB)
EFA/2010/008	27 July 2010	Action	Unsecured medical gas cylinders, including cylinders on trolleys Medical gas cylinders which are not secured properly can topple causing injury or death. This includes cylinders which may be free standing and those held in cylinder trolleys. (PDF 38KB)
MDA/2010/061	20 July 2010	Immediate	EEG recorder: NicoletOne® System. Manufactured by CareFusion 209 Inc, formerly Viasys Healthcare Inc. Software versions 5.3, 5.4 and 5.7. The standard NicoletOne System has a left/right (L/R) headbox configuration. However, NicoletOne Systems with software versions 5.3, 5.4, and 5.7 also have right/left (R/L) headbox configurations. There is potential for misinterpretation of EEG results when using the R/L configurations.(PDF 43 KB)
MDA/2010/060	14 July 10	Action	Sigmoidoscope and anoscope systems and accessories manufactured by Welch Allyn Limited. Endoscopes used for the examination of the large intestine and rectum. Potential cross-contamination from inadequate decontamination of reusable insufflation bulb and light head accessories. (PDF 23KB)
EFA/2010/007	8 July 10	Action	Window blinds with looped cords or chains. All types. Looped cords and chains on window blinds can present a strangulation hazard to children and vulnerable adults. There have been a number of deaths associated with these types of blind cords throughout the UK.(PDF 14MB)
MDA/2010/059	06 July 10	Immediate Action	Linear accelerator system. C-Series Clinacs manufactured by Varian Medical Systems Inc. Models H14, H27, H29 and HCX. A collision between the gantry and the patient may occur if a patient previously treated using a C-Series Clinac running version 6.X software is then treated using a C-Series Clinac running version 7.X software. This is due to differences in the Remote Auto Motion settings and rules between software versions 6.X and 7.X. When controlling the motion of the unit from the user console outside the treatment room, the couch safety zone no longer exists by default in version 7.X. (PDF 21KB)
MDA/2010/058	06 July 10	Immediate Action	GE Healthcare Anaesthetic CareStations. Models: Aespire 100/7100, Aespire 7900, Aespire View, Avance, Amingo, ADS 180. The O2 flush button can become impeded by the work surface of the care station and stick in the open or partially open position, resulting in flow of O2 into the breathing system. This may cause dilution of anaesthetic agent or barotrauma. (PDF 30 KB)
MDA/2010/057	30 June 10	Action	Alvema ITO pushchair for disabled children, manufactured by Eurovema AB and supplied in the UK by Rainbow Mobility Ltd. This includes: ITO Small with serial numbers from 104709 to 105306 inclusive and ITO Large with serial numbers from 104009 to 106789 inclusive. The frame tubes can break causing the pushchair to tip and injure the occupant or carer. Eurovema AB has issued a Field Safety Notice (FSN) but is unable to trace all the affected pushchairs. (PDF 28 KB)
MDA/2010/056	29 June 10	Immediate Action	Welch Allyn CP200 Electrocardiograph. When using the CP 200 in Auto ECG and Stat ECG modes, it is possible to print a previous patient’s ECG (without patient identifier) if the Auto ECG Post-Print screen is not exited properly in accordance with the manufacturer’s instructions. Consequently, there is a risk of patients receiving the wrong ECG report leading to misdiagnosis and incorrect treatment. (PDF 51 KB)
MDA/2010/055	29 June 10	Immediate Action	TruSat Pulse Oximeter manufactured by GE Healthcare (formerly Datex-Ohmeda). Part numbers: 605100000-190, 605100000-191, 605100000-192, 605100000-193. Possibility of excessive leakage current resulting in abnormal heart rhythm or burns. There is a potential electrical safety risk to the user when the device is running on the external power supply and the power supply connector is damaged or improperly connected on the TruSat. The manufacturer published a Field Safety Notice covering this issue on 2 June 2010, but has not received confirmation of its receipt from all customers. (PDF 48 KB)
MDA/2010/054	28 June 10	Action Update	Fetal monitor/cardiotocograph (CTG). Adverse outcomes are still being reported in the presence of CTG traces that appear normal. For example, the display of double maternal heart rate (MHR x 2) can be falsely reassuring. (PDF 49 KB)
MDA/2010/053	28 June 10	Immediate Action	All 5008 & 5008S Haemodialysis Machines manufactured before August 2008. Manufactured by Fresenius Medical Care AG & Co. KGaA. An electronic component may fail and cause the visual screen display of the haemodialysis machine to ‘black out’. The touch screen may still remain active/touch sensitive despite the visual screen failure. Smoke may also be released from the screen. (PDF 72 KB)
MDA/2010/052	28 June 10	Action	Anaesthetic vaporizers used to administer volatile agents for the maintenance of anaesthesia - all manufacturers. The MHRA has received reports where the failure to correctly attach vaporizers to the anaesthetic machine backbar has led to anaesthetic gas leakage and patient awareness. This may be more pronounced where: vaporizers are attached to anaesthetic machines from an alternative manufacturer / vaporizers are attached to the backbar during anaesthesia. (PDF 19 KB)
MDA/2010/051	21 June 10	Action	Appollo bath hoists. Models: Elegance, Excalibur and Appollo. Manufactured by Reva Industries Ltd; previously manufactured by Aquabeau or Airbath Appollo. There is a risk of the occupant sliding out of the seat and sustaining serious injury.(PDF 22 MB)
MDA/2010/050	16 June 10	Action	Implantable vagus nerve stimulators (VNS): Pulse and Pulse Duo Generators (Models 100, 101, 102 and 102R); Demipulse and Demipulse Duo Generators (Models 103 and 104); Model 250 programming software. Manufactured by Cyberonics VNS Therapy. Premature battery depletion (models 103 and 104). Inaccurate battery life projection (models 103, 104 and 250). Loss of therapy (all models). Painful, erratic or atypical stimulation (all models).(PDF 35 KB)
MDA/2010/049	15 June 10	Action	Liftmaster 160 and 190 electrical hoist manufactured by Patterson Medical Ltd (formerly Homecraft Rolyan Ltd and Smith & Nephew Homecraft Ltd) with boom and spreader bar assembly serial numbers SN4000001 to SN4001999 inclusive. The boom and spreader bar assembly may detach from the hoist during use, with the potential for the occupant to fall and sustain serious injury. Patterson Medical has issued a Field Safety Notice but is unable to trace all affected assemblies.(PDF 51 KB)
MDA/2010/048	10 June 2010	Action	Hepatitis C virus total antibody kit. ARCHITECT anti-HCV manufactured by Abbott GmbH & Co. KG. Distributed in the UK by Abbott Diagnostics. Product code 6C37-20, 6C37-25, 6C37-30. All lots. Rare potential for false negative HCV result which may lead to a missed diagnosis of hepatitis C infection. (PDF 35 KB)
EFA/2010/006	09 June 2010	Action	Self harm associated with profiling beds. (PDF 28 KB)
NIA/2010/001	02 June 2010	Action	Convector heaters, Micromark. Risk of fire. At least five incidents involving these heaters have been reported. (PDF 49 KB)
MDA/2010/047	02 June 2010	Action	Ondal Acrobat 2000 (AC2000) spring arm used to support operating lights and monitors made by various manufacturers. Specific serial numbers. There is the potential for metal fatigue fractures on the front joint of the spring arm to occur over time. There is an internal cable which will usually support the light or monitor if the arm fractures, but the cable could break and cause injury to the patient and staff. Ondal has issued guidance to the manufacturers that use these spring arms. Users should have been informed of this by their respective equipment supplier. A nonexhaustive list is attached. Users need to check the swing arm to establish if it has an Ondal label. (PDF 26 KB)
MDA/2010/046	02 June 2010	Immediate Action	UnilectTM ECG monitoring electrodes manufactured by Unomedical (a ConvaTec Company). Specific product and lot numbers. The gel on affected ECG monitoring electrodes may migrate from its normal position underneath the sponge to fill the position between the sensor and the snap connector. If this happens, the ECG monitor may fail to display the patient's ECG, potentially leading to delayed diagnosis or treatment. The manufacturer is recalling affected devices. (PDF 29 KB)
MDA/2010/045	27 May 2010	Action	Handle assembly fitted to monkey pole, model TGN-R100R, manufactured by Rolko GmbH. Supplied in the UK by Hill-Rom from January 2007 to January 2009 inclusive. The height adjuster can fail in use, resulting in the strap extending and the handle dropping. This may cause the patient to fall and sustain an injury. Hill-Rom has issued a Field Safety Notice but has been unable to trace all affected handle assemblies. (PDF 51 KB)
MDA/2010/044	25 May 2010	Action	DePuy ASRTM acetabular cups used in hip resurfacing arthroplastyand total hip replacement. The MHRA has received reports of higher than anticipated rates of revision for ASRTM acetabular cups. (PDF 30 KB) This Alert has been replaced by MDA-2010-069.
MDA/2010/043	20 May 2010	Action	Diathermy (electrosurgical) cables. Manufactured by Unomedical (a ConvaTec company). Product codes 3405M and 3508M. Specific batches. Certain batches of cables, used to connect Unomedical electrosurgical instruments to generators, have been supplied in mislabelled boxes. Boxes labelled with the code 3508M may contain a cable with the code 3405M, or vice versa. The two cables have different sized and shaped connectors and therefore cannot be used interchangeably. The cables can be readily distinguished from each other because they are colour coded:• green for product code 3405M• red for product code 3508M. The manufacturer has issued a Field Safety Notice but cannot be certain that all end users are aware of the problem. (PDF 26 KB)
MDA/2010/042	18 May 2010	Action	Therapy chair manufactured by Pronefro SA and supplied in the UK by Hymed Healthcare Products Ltd. The bracket securing the armrest can bend or break when an occupant applies their bodyweight to the armrest. This can lead to the occupant falling and sustaining serious injury. (PDF 40 KB)
MDA/2010/041	17 May 2010	Immediate	Visionary single-use laryngeal airway device (LAD). Manufactured by Marshall Products Ltd. There is the potential for the LAD connector to break when attached to other devices. This can cause patient ventilation to be interrupted until the airway is replaced. (PDF 27 KB)
MDA/2010/040	13 May 2010	Action	All chest drains when used with high-flow, low-vacuum suction systems (wall mounted). Direct connection between the chest drain bottle and the wall mounted, high-flow, low vacuum regulator without an intermediate jar or canister can lead to: • patient injury • loss of effective suction • contamination of the hospital vacuum system and infection hazard. (PDF 23 KB)
MDA/2010/039	12 May 2010	Action	All Aquarius haemofiltration machines. Manufactured by Edwards Lifesciences Ltd and supplied by Baxter Healthcare. Reports have been received of the wheels breaking due to wear or improper use. There is a risk of the machine toppling or falling over, which can cause injury and therapy interruption. (PDF 84 KB)
MDA/2010/038	12 May 2010	Action	X-ray detectable gauze swabs. RML122-044 10 cm x 7.5 cm 32ply. Lot number 090901. Manufactured by Rocialle. NHS Supply Chain Code: EM1235. Rocialle is recalling swabs from lot number 090901, which have been manufactured in two parts. If unfolded and opened out completely only one part of the swab has an X-ray detectable strip attached. Therefore, if the part of the swab without this strip is left inside the patient, it will not be detectable by X-ray examination. (PDF 39 KB)
MDA/2010/037	11 May 2010	Action	Peritoneal dialysis. Adult/paediatric Homechoice and Homechoice Pro automated system. Manufactured by Baxter Healthcare Ltd. Reports of patients experiencing overfilling of intra-peritoneal fluid (also referred to as increased intra-peritoneal volume or IIPV) arising from inappropriate programming of prescription parameters. (PDF 30 KB)
MDA/2010/036	06 May 2010	Action	All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators. The MHRA continues to receive reports of inadequate patient ventilation and oxygenation where harm could have been avoided if an alternative means of ventilation had been used earlier. These incidents occurred because of misconnection, entrapment or occlusion of the anaesthetic breathing systems, or because the anaesthetic machine or ventilator had failed. In one particular incident an anaesthetic breathing system was wrongly connected to the auxiliary common gas outlet of an anaesthetic machine. The effects of this were wrongly interpreted as bronchospasm and the usual drug regimens were administered. The time taken to finally identify that this was a problem with the equipment meant that the patient was harmed. Whilst such equipment issues are uncommon, they should be considered as a matter of course when problems with patient ventilation occur. (PDF 25 KB)
MDA/2010/035	05 May 2010	Immediate Action	Angiography X-ray system: AXIOM Artis systems with Polydoros A100 generators manufactured by Siemens Healthcare. Specific devices (see appendix). The system may fail to expose as a result of a contact problem at the low voltage power supply of the generator controller. This may occur spontaneously and may not be foreseeable. No images would be available to the user, potentially delaying diagnosis or treatment. Temporary screening may be achieved by repeatedly pressing and releasing the footswitch. The problem was discovered during product monitoring and Siemens Healthcare has received no reports of this incident occurring in the field. (PDF 22 KB)
MDA-2010-034	27 April 2010	Action	Alaris GP and Alaris GP Guardrails volumetric pump with Plus software. Manufactured by CareFusion, branded as Cardinal Health. Models 9002MED01 and 9002MED01-G. Software version 2.1.12. Due to a software irregularity, if the previous set up is not cleared at start-up, the single bubble detection threshold will default to 100 microlitres, without any indication to the user. If the desired setting is less than 100 microlitres, there is the potential for serious injury, particularly to neonates. If the desired setting is greater than 100 microlitres, there is the potential for an increase in nuisance alarms.(PDF 1.6 KB)
MDA/2010/033	22 April 2010	Action	This Alert has been replaced by MDA-2012-036’.
MDA/2010/032	20 April 2010	Immediate Action	Shiley cuffed tracheostomy tubes. Manufactured by Covidien (formerly Tyco Healthcare). Specific lot numbers. Slow cuff deflation, which can result in aspiration or inadequate ventilation. Covidien is recalling affected devices. (PDF 25 KB)
MDA/2010/031	20 April 2010	Action	Arcoma ‘ArcoTable NT’ for use with X-ray systems. Model 0055. Unexpected collapse of the table support columns may lead to patient or staff injury. (PDF 72 KB)
MDA/2010/030	15 April 2010	Immediate Action	Blood glucose meters. 5-second CONTOUR® manufactured by Bayer Diabetes Care. Affected devices may show falsely high readings when testing samples from neonates. Hypoglycaemia may go undiagnosed as a result. (PDF 36 KB)
MDA/2010/029	14 April 2010	Action	Mobile hoists. Arjo Minstrel standard type HMA001 and EPC type HMA0011 manufactured by Medibo Medical NV. Inaccurate maintenance instructions and poor inspection of hanger bar attachment. Attachments have failed in use leading to a fall and injury to the person being moved. (PDF 34 KB)
MDA/2010/028	14 April 2010	Action	Enteral feeding administration sets. Applix Smart pump sets. Manufactured by Fresenius Kabi. Risk of non-delivery of enteral feed. Due to a manufacturing problem, the antifree flow clamp may not automatically open when the set is inserted into the enteral feed pump and its door is closed. The manufacturer has issued a Field Safety Notice, but omitted to include actions to be taken when priming the set by gravity. (PDF 178 KB)
MDA/2010/027	08 April 2010	Action	Endotracheal (ET) tubes, adult and paediatric sizes. Manufactured by Unomedical (a ConvaTec company). Risk of inadvertent disconnection of the endotracheal tube from the breathing system, interrupting patient ventilation until the tube is reconnected or replaced. (PDF 41 KB)
MDA/2010/026	08 April 2010	Immediate Action	PediCap 6 paediatric end-tidal CO2 detector manufactured by Covidien (part of Tyco Healthcare) Specific lot numbers. A modification to the indicator paper in the detector may result in: increased resistance to airflow; inadequate sensing of carbon dioxide (CO2), as the indicator does not change colour; delay in detection of an incorrectly placed breathing tube. (PDF 39 KB)
EFA/2010/005	08 April 2010	Action	TASKI – Ergodisc Duo Type 43LHSL machine for wet scrubbing / stripping / buffing floors, manufactured by Diversey Ltd. There is a risk of switch failure, meaning that the machine cannot be switched off with the hand levers and has to be disconnected from mains to stop it. When next used, a faulty machine will start immediately on bieng "plugged" resulting in uncontrooled operation and risk of injury/damage to anyone/anything in the near vicinity. The TASKI machines have been used in the UK for some 20 years. The manufacturer has advised that this problem has so far only been observed on older machines which have been in regularly daily use. (PDF 916 KB)
EFA/2010/004	07 April 2010	Immediate Action	GN9120 wireless headset manufactured by GN Netcom Inc for use with professional telephony systems. An internal short circuit in the Amperex Technology Ltd (ATL) lithium-ion polymer batteries, which was used in some of these devices, can cause the batteries to overheat, resulting in a risk of injury and/or fire. Implicated batteries were sold from January 2005 to September 2008 as part of the headset and as a replacement part. (PDF 157 KB)
MDA/2010/025	31 Mar 2010	Immediate Action	Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All models and lot numbers. On Tuesday 30 March 2010 the French medical device regulatory authority (AFSSAPS) informed the MHRA that it has suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer). It has recalled all of these devices. (PDF 27 KB) Please note further advice is given in MDA/2012/011
EFA/2010/003	29 Mar 2010	Action	Anti-ligature curtain rails (including shower curtains): risks from incorrect installation or modification (PDF 27 KB)
MDA/2010/024	23 Mar 2010	Immediate Action	This alert has been replaced by MDA/2010/027
MDA/2010/023	23 Mar 2010	Immediate Action	Intracranial stent: SILK artery reconstruction device manufactured by Balt Extrusion and distributed in the UK by Pyramed Ltd. Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils. (PDF 600 KB)
EFA/2010/002	16 Mar 2010	Action	Access hatches. Examine all access hatches and ensure unauthorised persons cannot open them. Where the hatch forms a means of escape from the area above, any device used to secure the hatch from the public side must not compromise the exit from the concealed side. (PDF 36 KB)
EFA/2010/001a	16 Mar 2010	Action	Medical Patient Weighing Scales. Medical weighing equipment used in healthcare premises may be inaccurate, inappropriate or not used correctly, leading to potential errors in diagnosis, treatment or medication of patients. (PDF 50 KB
MDA/2010/022	10 Mar 2010	Immediate Action	Hoists and standing aids. Models: Cricket-3, Cypress-2, Ergolift, Ergolift 600, Ergostand, Explorer, Explorer 600, Graduate, Junior, Medilifter-IV, Mezzo, Ministand, ML-4, Primo, Sherpa, SSL-2, Standup, Trekker and Xtreme. Manufactured by BHM Medical Inc. Risk of electric shock when the hoist is connected to the mains supply with a single insulated power cable for battery charging.(PDF 19 KB)
MDA/2010/021	10 Mar 2010	Immediate Action	Anaesthetic gas scavenging systems (AGSS). All manufacturers. Risk of serious harm to the patient from excessive pressure un anaesthetic breathing systems caused by blockage of AGSS hoses.(PDF 23 KB)
MDA/2010/020	9 Mar 2010	Immediate Action	Hansen type coloured connectors on dialysis fluid lines used on Dialysis and Haemodiafiltration machines. All manufacturers. Potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) resulting in a significantly less efficient dialysis. (PDF 19 KB)
MDA/2010/019	09 Mar 2010	Action	All types of Oxford slings and standing harnesses manufactured by Joerns Healthcare Ltd for use with hoists and stand aids. Unclear instructions for use. The MHRA has received various incident reports where occupants have been injured as a result of incorrect use or inadequate inspections of slings before use. (PDF 19 KB)
MDA/2010/018	09 Mar 2010	Action	All models of mobile hoists, ceiling hoists and bathing lifts manufactured by Joerns Healthcare Ltd. Lack of maintenance and inspection of these devices could lead to the occupant falling and being seriously injured. (PDF 14 KB)
MDA/2010/017	08 Mar 2010	Immediate	Peripheral cannula. Nexiva closed IV catheter system with Q-Syte connector. Manufactured by Becton Dickinson. The manufacturer has received reports of air entering into infusion lines through the BD Q-Syte connector. Risk of air embolus to patients. This problem is an extension of the original action detailed in MDA/2009/075. (PDF 39 KB)
MDA/2010/016	08 Mar 2010	Action	Pregnancy test for professional use. Clearview hCG Combo manufactured by Unipath Limited. Product code 506760. Distributed between July 2008 and August 2009. False positive results may be observed when the test results are interpreted after:3 minutes for urine samples, 5 minutes for serum samples. Specific product lot numbers contain instructions for use that have since been updated. (PDF 139 KB)
MDA/2010/015	26 Feb 2010	Immediate Action	Powerheart AED G3 automatic external defibrillators (AEDs) manufactured by Cardiac Science Corporation Specific serial numbers. Affected AEDs may fail to deliver a shock due to an internal short-circuit. This is a separate problem to that described in MDA/2010/014 and a different range of serial numbers are affected (PDF 32 KB)
MDA/2010/014	18 Feb 2010	Action	Powerheat AED G3 and cardioVive automatic external defibrillators (AEDs) manufactured by Cardiac Science Corporation. There is a small risk that the AED may not deliver a shock. The software self-test may not detect a fault with a specific internal component, so the AED may not be able to deliver a shock during a rescue attempt (PDF 32KB)
MDA/2012/013	18 Feb 2010	Action	Arjo Passive Clip sling and Arjo Passive Clip Flite slings manufactured by Medibo. Incorrect attachment of the sling clips to the spreader bar. This can lead to the person in the sling falling out and injuring themselves or others (PDF 19 KB)
MDA/2010/012	10 Feb 2010	Immediate	Teligen implantable cardioverter defibrillators (ICDs) and Cognis cardiac resynchronisation therapy defibrillators (CRT-Ds) – specific models. Manufactured by Boston Scientific / For devices implanted subpectorally there are risks of: • loss of shock therapy • inappropriate shock therapy • loss of pacing therapy • loss of anti-tachycardia pacing (PDF 39 KB)
MDA/2010/011	8 Feb 2010	Immediate	Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet) / Excessive negative pressures (e.g. using closed suction systems) can damage the inspiratory and expiratory pressure measurement transducers. Such damage has lead to high gas flows that subsequently caused bilateral pneumothoraces (PDF 52 KB)
MDA/2010/010	01 Feb 2010	Action	C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT) / There is a risk of injury to the attendant’s hand, by the climbing mechanism, if the stair climber is activated when two people are moving it (PDF 110 KB)
MDA/2010/009	28 Jan 2010	Immediate Action	T-piece connector incorporated into various breathing systems. Manufactured by Intersurgical Ltd. Possible occlusion of the connector by a plastic membrane caused by a moulding fault during manufacture. This fault could prevent or restrict the gas flow to the patient (PDF 35 KB)
MDA/2010/008	21 Jan 2010	Action	Intraocular Lens (IOL) - Hydrophilic Acrylic. Opacification of IOLs may occur following intracameral use of alteplase (recombinant tissue plasminogen activator, r-tPA) (PDF 23 KB)
MDA/2010/007	19 Jan 2010	Action	All pole clamps for Infusomat Space and Perfusor Space infusion pumps. Manufactured by B Braun. Part number 8713130. If the manufacturer’s instructions for use are not followed and the pole clamp components are damaged or missing following use, there is a risk of detachment of the infusion pump from the pole clamp with subsequent damage (PDF 67 KB)
MDA/2010/006	18 Jan 2010	Action	Devices used for endometrial ablation. All makes and models / The MHRA continues to receive reports of uterine wall injury, wall perforation, or the creation of a false passage following use of endometrial ablation devices. In some cases resection of damaged tissue has been required. The majority of complications occur due to either poor patient selection or endometrial ablation procedures being performed in difficult situations. Patients with either a retroverted uterus or a fixed uterus (e.g. due to significant endometriosis or adhesions), or those that have had previous uterine surgery are at a higher risk (PDF 31 KB)
MDA/2010/005	13 Jan 2010	Action	GE patient tables for use with GE X-ray systems (Proteus XR/a, Revolution XR/d and Definium 8000 systems) with table model numbers 2259988, 2259988-2, 2351505 and 5131070. Unexpected movement of the floating tabletop due to failure of the brake mechanism. There is a risk of injury as a patient may lose balance when getting on or off the table (PDF 32 KB)
MDA/2010/004	11 Jan 2010	Action	Action 3 and Action 4 manual wheelchairs manufactured by Invacare / Invacare has revised the instructions for use for various safety related aspects. Users who are unaware of these revised instructions are at risk of injury. In particular, from a fall due to instability or from positional asphyxiation due to poor lap belt position, fitting or adjustment (PDF 50 KB)
MDA/2010/003	05 Jan 2010	Action	Universal cables for use with ConMed Linvatec surgical power tools. Device catalogue number MC5057. Only cables manufactured before 01 December 2006 are affected / There is a possibility that a worn or damaged power cable may cause the handpiece to selfactivate. ConMed Linvatec issued a Field Safety Notice on this problem in September 2009 (PDF 33 KB)
MDA/2010/002	05 Jan 2010	Action	All types of bed mattresses / If mattress covers are damaged, body or other fluids can pass through and contaminate the inner core. There is the potential for cross-infection if contaminated mattresses remain in use (PDF 30 KB)
MDA/2010/001	4 Jan 2010	Action	Medical devices in general and non-medical products / 1.Off-label use of medical devices 2. User modifications of devices other than directed by the device manufacturer 3. Use of products, other than those that are CE-marked as medical devices, for clinical purposes (PDF 29 KB)
EFA/2009/002	30 Dec 2009	Action	Suspension systems for operating theatre equipment: risk of support arm failure / Support arms on suspension systems for equipment (operating lights etc) in theatres / procedure rooms could fail following collisions with other equipment and/or ageing and should be inspected routinely (PDF 77 KB)