NIAIC

Medical Device and Equipment Alerts MDEA Updates - 2009

Number	Issue Date	Level Of Urgency	Title
EFA/2010/001	12 Jan 10	Action	UK-wide Estates & Facilities Alert (EFA) - A change to the format of the safety warning Alerts published by the Northern Ireland Adverse Incident Centre (NIAIC) (PDF 53 KB)
MDA(NI)2009/085	18 Dec 09	Action	GE Fluoro uninterruptible power supply units (UPS) 20KVA associated with Innova cardiovascular X-ray imaging systems - The UPS battery can degrade and its life expectancy may be shortened, potentially causing the UPS to become unavailable. This may result in sudden curtailment of examinations with serious consequences for patient diagnosis or treatment. (PDF 40 KB)
MDA(NI)2009/084	16 Dec 09	Action Update	LIFEPAK CR ® Plus automatic external defibrillator manufactured by Medtronic Physio-Contro Specific serial numbers. Failure to deliver therapy. A faulty internal cable in defibrillators manufactured from November 2006 to March 2008 inclusive may prevent the defibrillator from switching on. The manufacturer has restarted their upgrade program and any outstanding devices should now receive the corrective action (PDF 38 KB)
MDA(NI)2009/083	16 Dec 09	Immediate Action	MiniMed Paradigm Veo insulin pump manufactured by Medtronic. All serial numbers. Two functions on this pump do not work correctly: wireless meter reading and missed bolus reminder. There is a potential for inappropriate insulin administration (PDF 38 KB)
MDA(NI)2009/082	14 Dec 09	Action	Birdie mobile hoists manufactured by Invacare - The legs of the base can detach and cause the hoist to tip in use, leading to injury to the occupant or others (PDF 35 KB)
MDA(NI)2009/081	14 Dec 09	Action	Rea Azalea wheelchairs manufactured by Invacare Rea AB - There are two problems which can cause the occupant to fall from the wheelchair and sustain a serious injury: 1. the backrest can fail in use 2. the posture belt can loosen if fitted or adjusted incorrectly (PDF 279 KB)
MDA(NI)2009/080	09 Dec 09	Action	Ultrasound transducer probes with an internal lumen used for taking transrectal prostate biopsies. Potential onward transmission of abnormal prion protein, the putative infective agent in variant Creutzfeldt Jakob disease (vCJD), when ultrasound transducer probes with an internal lumen are used for taking transrectal prostate biopsies on men at risk of vCJD (PDF 26 KB)
MDA(NI)2009/079	08 Dec 09	Action	Martin Heavy Duty manual wheelchair manufactured by Karma Mobility Ltd. The backrest can fail in use causing the occupant to fall from the wheelchair resulting in serious injury (PDF 86 KB)
MDA(NI)2009/078	08 Dec 09	Action	Intra-aortic balloon pump harness safety system supplied for use with the CS300 balloon pump.Supplied by Datascope, now Maquet. The harness was not designed to be used with the CS300 balloon pump and therefore does not adequately secure it during ambulance transportation (PDF 86 KB)
MDA(NI)2009/077	24 Nov 09	Action	X-ray detectable gauze swabs – sterile and non-sterile. Swabx manufactured by Richardson Healthcare Limited. The X-ray filament within the swab is of insufficient tensile strength, which may cause the thread to fragment during use. Richardson Healthcare is recalling specific lot numbers of Swabx X-ray detectable gauze swabs (PDF 3.6MB)
MDA(NI)2009/076	24 Nov 09	Action	Aquarius haemofiltration machine. Software versions 3.52, 4.01.11, 4.01.12 and 6.01. Manufactured by Edwards Lifesciences Ltd. This Alert provides an update on actions taken by Edwards Lifesciences, as advised in MDA/2009/012. Software versions 3.52, 4.01.11 and 4.01.12 These machines will not have their software upgraded as previously intended. An ongoing training package, a warning sticker and laminated instruction sheet will be provided for each machine. Software version 6.01. These machines are due to have their software upgraded as previously advised. Edwards Lifesciences is unable to confirm when the updated software will be available for implementation. In the meantime, Edwards Lifesciences will provide an interim training package as described for the above software versions (PDF 4MB)
MDA(NI)2009/075	18 Nov 09	Immediate Action	Needle-free intravascular connectors: • BD Q-Syte stand-alone Luer access split septum connector • BD Q-Syte with 15cm micro bore extension set. Manufactured by Becton Dickinson. The manufacturer has received reports of air leaking into infusion lines through the BD Q-Syte connector. Risk of air embolus to patients (PDF 57 KB)
MDA(NI)2009/074	12 Nov 09	Immediate Action	This alert has been replaced by MDA/2010/011 (PDF 53KB)
MDA(NI)2009/073	11 Nov 09	Action	Oxygen therapy. Multifit nebulizer and Multifit nebulizer with BOC adaptor. Manufactured by Teleflex. Failure to provide humidification due to a manufacturing defect. This could result in patients developing dry airways, causing discomfort and irritation. The manufacturer is recalling specific batches. No other batch numbers are affected (PDF 29 KB)
MDA(NI)2009/072	09 Nov 09	Action	Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare (formerly Datex-Ohmeda). Also distributed by Baxter Healthcare / There is a higher than expected age related failure of an internal component, which has resulted in either over or under delivery of anaesthetic agent to patients (PDF 39 KB)
MDA(NI)2009/071	05 Nov 09	Action	Adapters used to attach LikoScale weighing systems models 200, 350 and 400 to patient hoists. Manufactured by Liko, a Hill-Rom company / Adapters that connect the weighing scale to the hoist can fail in use, resulting in a fall and serious injury to the occupant (PDF 42 KB)
MDA(NI)2009/070	05 Nov 09	Action	Urine test strips. Uritest 13G manufactured by URIT Medical Electronic. Distributed in the UK by Econo-Med Ltd.All batches / Potential for misdiagnosis due to poor analytical precision and sensitivity when testing for low levels of microalbumin and creatinine in urine. Risk of poor impregnation of the microalbumin and creatinine test pads by the sample, due to their position at the top on the strip. No instructions for use are provided by the company to aid visual interpretation of the test (PDF 238 KB)
MDA(NI)2009/069	03 Nov 09	Action	Home test kits: Simplicity Health prostate screening and Fortel prostate specific antigen test. Affected lot no. 1012 Manufactured by Biomerica Inc USA. Distributed in the UK by: - BHR Pharmaceuticals Ltd - Simplicity Health Ltd / Risk of false negative results which could lead to a missed diagnosis of prostate cancer (PDF 87 KB
MDA(NI)2009/068	02 Nov 09	Action	Careline EasiMT urine collection bag manufactured by Unomedical Ltd. Product code 47-60-LBH. Affected batch number 327241. NHS Supply Chain code GDW031 / A faulty valve has been used in the manufacture of batch 327241 resulting in leaks (PDF 50 KB)
MDA(NI)2009/067	27 Oct 09	Action	Aluminium double adjustable elbow crutches model RM 512700 manufactured by Trulife Limited / Due to a manufacturing error the handle can give way in use. This can lead to loss of stability or a fall, with the potential for serious injury (PDF 38 KB)
MDA(NI)2009/066	26 Oct 09	Action	Battery chargers supplied with Aquila and Neptune bath lifts manufactured by Mountway Ltd. The surface of the battery charger can get excessively hot in use. There is potential for injury if the unit is touched, especially for those with low skin sensitivity or poor circulation (PDF 53 KB)
MDA(NI)2009/065	22 Oct 09	Action	Escape 338S/SN Lite manual wheelchair manufactured by Days Healthcare Ltd. Contrary to information in the original instructions for use, this model of wheelchair is not suitable for use as a seat in a motor vehicle. The wheelchair could fail in a vehicle impact, leading to injury of the wheelchair occupant or others (PDF 45 KB)
MDA(NI)2009/064	15 Oct 09	Action	Harrier powered wheelchairs manufactured by Invacare. Models Plus, HD and XHD. Invacare has revised the instructions for use for various safety aspects. Users who are unaware of these new limitations are at risk of injury (PDF 89 KB)
MDA(NI)2009/063	14 Oct 09	Immediate Action	Endotracheal tube. Portex uncuffed paediatric tracheal tubes, manufactured by Smiths Medical. A manufacturing defect has resulted in some tubes having an internal diameter slightly smaller than indicated on the labelling. The small diameter may cause a problem when suctioning a patient, and may also increase airway resistance, compromising the ability to ventilate the patient (PDF 58 KB)
MDA(NI)2009/062	14 Oct 09	Action	Knee replacement implant. PFC Sigma cruciate retaining non-porous size 5 left femoral component (part number 960005) manufactured by DePuy International Limited. Specific lots. A manufacturing defect on the posterior chamfer region may result in fracture of the device (PDF 57 KB)
MDA(NI)2009/061	09 Oct 09	Action	Rea Assist wheelchairs manufactured by Invacare Rea AB. Due to an ineffective locking mechanism the backrest may suddenly detach and cause the user to fall from the wheelchair, resulting in serious injury (PDF 2.3MB)
MDA(NI)2009/060	22 Sept 2009	Immediate	Dialysis bloodlines.AV-SET Dialog® GB Product code 7210697. Manufactured by BBraun Avitum AG.Blood leakage at the arterial chamber (PBE chamber) junction (PDF 88 KB)
MDA(NI)2009/059	14 Sep 09	Action	Arjo Maxilift patient hoists manufactured by Arjo Med AB Ltd. On certain designs of hoist, the hanger bar can detach from the jib during use due to corrosion and fatigue of the roll pin. This can cause the occupant to fall with subsequent serious injury or death (PDF 46KB)
MDA(N)2009/058	25 Aug 09	Action	Welch Allyn vital signs monitorVSM 300 / Failure of the audible alarm with potential for delay in recognising critical clinical signs (PDF 58KB)
MDA(NI)2009/057	20 Aug 09	Action	Smart mobile hoists manufactured by Molift Group AS / Potential for the collapse of the hoist mast when in use due to incorrect assembly. This can result in serious injury or death (PDF 28KB)
MDA(NI)2009/056	19 Aug 09	Immediate Action	This alert has been replaced by MDA/2010/011 (PDF 53KB)
MDA(NI)2009/055	18 Aug 09	Immediate Action	Intro-Flex introducers manufactured by Edwards Lifesciences Ltd for the insertion of Swan-Ganz catheters. Specific batches of specific models. The blue connector on the introducer may break during use, which may result in significant blood loss. The manufacturer is recalling all affected devices (PDF 49KB)
MDA(NI)2009/054	11 Aug 09	Action	Pregnancy test for professional use. Clearview HCG manufactured by Unipath Limited. Product code 506788 (all lot numbers). Distributed from January 2008. False positive results may be observed when the test results are interpreted beyond 3 minutes (PDF 48KB)
MDA(NI)2009/053	5 Aug 09	Action	Manual wheelchairs. Breezy 100 and Breezy 300 ranges. Manufactured by Sunrise Medical Ltd. These wheelchairs are not suitable for use as a seat in a motor vehicle unless they have been fitted with a transit kit. Without this kit the wheelchair could break loose in a vehicle impact, leading to injury of the wheelchair user or others (PDF 241KB)
MDA(NI)2009/052	4 Aug 09	Action	IVD INSTRUMENTATION: DS2 automated microplate processing system. Manufactured by Dynex Technologies. DS2 units with serial numbers less than 1DSA-0309 e.g 1DSA-0308, 1DSA-0307 etc. Delay in reporting of laboratory results, which may lead to a delay in treatment or diagnosis (PDF 48KB)
MDA(NI)2009/051	3 Aug 09	Immediate	This alert has been suspended pending further investigation. Thermo contour mattress for hospital beds. Manufactured by Barrington Healthcare International Ltd. Supplied by Hill-Rom.(PDF 32 KB)
MDA(NI)2009/050	29 July 09	Action	Hospital beds - Eleganza Standard, Smart and Deluxe supplied by Pegasus or Linet / Reminder that the emergency backrest release function on these beds may fail or become stiff and difficult to operate. This could lead to a delay in performing CPR (PDF 92KB)
MDA(NI)2009/049	29 July 09	Immediate	Agfa IMPAX 6.x when used in conjunction with TMVSE Voxar 3D 5.1 / Risk of incorrect or delayed treatment or diagnosis. Multi-planar eformat imaging data created by Voxar 3D may be lost by Agfa IMPAX system during transfer (PDF 97KB)
MDA(NI)2009/048	29 July 09	Action	All University bath hoists manufactured by Unihoist Ltd / If the seat is used without a safety belt there is a risk that the occupant slides out of the seat and sustains a serious injury (PDF 39KB)
MDA(NI)2009/047	27 July 09	Action	Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks, manufactured by Arrow®. Risk of leakage or air embolism due to hub cracking at the female Luer connector during delivery of infusions containing lipids (PDF 47KB)
MDA(NI)2009/046	20 July 09	Action	Modular knee/hip replacement systems. MRS Cemented Stems manufactured by Stryker Orthopaedics. Specific lots. Small diameter stems (8, 9 or 10 mm) may have been incorrectly implanted in the proximal femur and be at risk of fracture (PDF 46KB)
MDA(NI)2009/045	20 July 09	Immediate	First Steps medicine feeder. Item number FS012 – various colours. Manufactured by RSW International Ltd. The medicine feeder has two measurement scales, millilitres (ml) and teaspoons (tsp). Confusion between the scales has led to a serious overdose in a six month old infant who was repeatedly administered 2.5 tsp (~13ml) of medication instead of 2.5ml. The manufacturer has recalled this product (PDF 134KB)
MDA(NI)2009/044	15 July 09	Action	Surgical gloves. Esteem® Blue with Neu-Thera™ polyisoprene surgeon undergloves. Manufactured by Cardinal Health. Lot numbers TS0409472 to TS09020495 (inclusive). Gloves from the affected lots can tear more easily, increasing the risk of infection (PDF 46KB)
MDA(NI)2009/043	9 July 09	Action	Drainage catheters: Flexima™ and Percuflex™ drainage catheter family (pigtail style,peripheral interventions). Percuflex™ and percutaneous model drainage catheter family (urology). Manufactured by Boston Scientific. All product codes and lot numbers are affected. On removing the catheter there is a risk that the suture keeping the pig tail shape in place, remains in the patient (PDF 25KB)
MDA(NI)2009/042	29 Jun 09	Action	Servo 300 ventilator (SV300) manufactured by Siemens (now Maquet). The expiration valve may fail to close, leading to a risk of hypoxia if corresponding ventilator alarms are ignored (PDF 64KB)
MDA(NI)2009/041	22 Jun 09	Action	Locomotor lifting slings for adults and children manufactured by Select Healthcare (UK) Ltd. Potential for straps to detach in use ifsafety-critical stitching is missing. This can cause the occupant to fall from the sling with the potential for serious injury or death (PDF 34KB)
MDA(NI)2009/040	18 Jun 09	Immediate Action	Heliosphere Bag® Intragastric Balloon manufactured by Helioscopie Medical Implants and distributed in the UK by UK Surgical. Affected batches supplied in the UK: 08IN328-8 and 08IN328-10. Possible bowel obstruction due to full or partial early deflation of the balloon during the intended six months implantation period caused by a manufacturing welding problem (PDF 374KB)
MDA(NI)2009/039	16 Jun 09	Immediate Action	Prelude Short Sheath Introducer manufactured by Merit Medical. All batches of specific models affected. The sidearm tubing may detach from the sheath during use, which may result in excessive blood loss and potential bloodborne pathogen exposure to those in the surrounding area (PDF 34KB)
MDA(NI)2009/038	10 Jun 09	Immediate Action	Implantable pacemakers. Medtronic Kappa® 600/700/900 series and Sigma® 100/200/300 series IPGs. Specific serial numbers may be entered online to determine if they are affected(http://KappaSigmaSNList.medtronic.com). Certain Kappa® and Sigma® series pacemakers may suffer sudden unexpected failure giving rise to bradycardia symptoms (fainting or light headedness). Serious injury or death may occur in pacemaker dependent patients (PDF 36KB)
MDA(NI)2009/037	4 June 09	Action	Knee replacement implant. Preservation mobile bearing unicompartmental knee manufactured by DePuy International Limited. Revision rate higher than expected (PDF 30KB)
MDA(NI)2009/036	2 June 09	Action	Intravenous burette administration set manufactured by Codan. Product code 593310. Batch numbers F74916-1 and F74916-2 only. NHS Supply Chain code FSB003 (England only). The manufacturer has identified the potential for leakage from the drip chamber of certain burette sets. This could result in inadequate intravenous administration (PDF 30KB)
MDA(NI)2009/035	1 June 09	Action	Infusion pumps. Colleague single and triple-channel volumetric infusion pumps manufactured by Baxter. Models: Mono and CXE. Product codes: 2M8151K, 2M8153K, 2M8161K, 2M8163K, 2M9161 and 2M9163. Risk of interruption of infusions due to: 1. software faults resulting in the pump stopping and alarming. It may not be possible to restart an affected pump. 2. increased occurrence of ‘damaged battery’ messages. 3. damage from improper cleaning (PDF 40KB)
MDA(NI)2009/034	1 June 09	Action	Suction catheters. OP-Flex Poole (handle and set) manufactured by Unomedical Limited. Risk of the suction catheter’s outer Poole cover detaching from the handle and remaining in the patient due to a manufacturing fault (PDF 73KB)
MDA(NI)2009/033	11 May 09	Action	Posture (hip) belts for use on paediatric seating systems and buggies. Manufactured and supplied by R82 between 27 May 2008 and 31 August 2008 The belt has been manufactured from material that is too thin and this could slip through the buckles when the belt is in use. Consequently the occupant could slide down in the seat and suffer positional asphyxiation (PDF 506KB)
MDA(NI)2009/032	29 Apr 09	Action	Bioprosthetic heart valves. All makes and models. Early valve revision with associated morbidity or mortality risks if these valves are not adequately washed or rinsed prior to implantation. Residues of chemicals typically used in the storage of bioprosthetic heart valves can adversely affect the patient’s annular tissue and lead to premature failure of the valve (PDF 39KB)
MDA(NI)2009/031	28 Apr 09	Immediate Action	Paediatric tracheostomy tubes. Shiley 3.O PED manufactured by Tyco Healthcare (now Covidien). It may be difficult to insert the obturator or a suction catheter into some Shiley 3.0 PED cuffless paediatric tracheostomy tubes due to a manufacturing problem (PDF 38KB)
MDEA(NI)2009/003	27 April 09	Action	ASDA ‘Durabrand’ domestic microwave oven XB2316: recall due to risk of fire / A manufacturing fault on ASDA ‘Durabrand’ domestic microwave ovens (model XB2316) has resulted in a risk of overheating and fire. The supplier issued a product recall notice in February 2008(PDF 25KB)
MDA(NI)2009/030	27 April 09	Action	Disposable endoscopic polypectomy snares manufactured by ConMed. Specific product and lot codes. There is a risk that the snare loop may detach and fall into the patient’s stomach or alimentary canal, requiring an additional procedure to remove it (PDF 45KB)
MDA(NI)2009/029	21 April 09	Immediate Action	Automatic external defibrillator: Welch Allyn AED 10 (previously branded as MRL JumpStart). Specific serial numbers are affected. Used in hospitals, ambulances and public places. Device recall due to quality and performance problems. Devices can fail suddenly and prevent defibrillation of a patient (PDF 835KB)
MDA(NI)2009/028	21 April 09	Action	Goldmann applanation tonometer prism. Manufactured by Haag-Streit Ag. Damage to the tonometer prism due to the use of inappropriate disinfectants may result in corneal irritation (PDF 446 KB)
MDA(NI)2009/027	20 April 09	Immediate Action	Ambulatory insulin infusion pump. Accu-Chek Spirit manufactured by Roche Diagnostics. Only serial numbers up to and including 10006093 are affected (number is located on the back of the pump). Due to a design fault, the ‘up’ and ‘down’ arrow buttons can fail. If both the buttons fail at the same time, the activation of the bolus function and the adjustment of the preset basal function will be inhibited. This means that there is a risk that insulin therapy is compromised (PDF 439KB)
MDA(NI)2009/026	15 April 09	Immediate Action	GE Healthcare Anaesthetic CareStations. Affected models Aisys and Avance. Serial number ranges Aisys: ANAH00100-ANAM00498 Avance: ANBG00100-ANBM00530. An intermittent electrical connection with the On/standby switch can cause the machine to shutdown unexpectedly. The machine alarms and then a message appears on screen stating ‘System Shutdown in 8 seconds’ (PDF 569KB)
MDA(NI)2009/025	8 April 09	Action	Mikrozid® sensitive wipes (alcohol free surface disinfection wipes for medical devices) manufactured by Schulke & Mayr. Tub (product code 109184) and refill pouches (product code 109190). The disinfecting property of the Mikrozid sensitive wipe cannot be guaranteed. (PDF 402KB)
MDEA(NI)2009/002	16 April 09	Action	Operating Theatre Lamps. Operating theatre lamps should continue to function on battery if the normal electrical supply fails. Consideration should also be given to battery back-up in case the operating lamp control unit fail (PDF 62KB)
MDA(NI)2009/024	6 April 09	Immediate	This alert has been replaced by MDA(NI)2009-027 (PDF 440KB)
MDEA(NI)2009/001	26 Mar 09	Action	GEMU steam valve actuator model : CN 33548 Manufacturer No : 1993208 (manufactured prior to 12th July 2004) Escape of steam under pressure with the potential to cause injury. A steam valve actuator supplying steam to an autoclave (sterilizer) failed allowing steam to escape under pressure into the atmosphere (PDF 24KB)
MDA(NI)2009/023	2 April 09	Action	Zenith® abdominal aortic aneurysm (AAA) endovascular grafts and associated H&L-B One-ShotTM Introduction Systems. Manufactured by Cook Medical Incorporated. Potential for serious injury or death of the patient due to difficulty releasing or inability to release the suprarenal stent during graft deployment (PDF 496KB)
MDA(NI)2009/022	31 Mar 09	Immediate Action	Posture belt manufactured by James Leckey Designs Ltd for use on their paediatric seating systems: Mobile Advance Seat Contoured Advance Seat Squiggles Early Sitting System Squiggles Saddle Seat. The central plastic buckle degrades and can fail in use. This may result in the occupant falling from the seat and injuring themselves (PDF 149KB)
MDA(NI)2009/021	27 Mar 09	Immediate	Insulin pen needles: Labelled as Novo Nordisk Ltd Novofine® Needles 31G, 0.25 mm x 6 mm lot number 08J02S / Counterfeit Novofine needles have been placed on the UK market. Affected products bear the lot number 08J02S. Use of counterfeit needles could lead to a number of adverse health outcomes, including infection (PDF 44KB)
MDA(NI)2009/020	25 Mar 09	Action	All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens). Risk of inadequate ventilation of neonatal or paediatric patients without warning by any alarm (PDF 348KB)
MDA(NI)2009/019	18 Mar 09	Immediate Action	Insulin pen injection devices: Owen Mumford Autopen® Classic (1 unit 3ml), 1- 21 units. Product code: AN3810 Affected lots: CJF, DBR, DEX, DMP, DND BRG and CCW. Affected devices may fail to dispense insulin. Underdosing of insulin may lead to hyperglycaemia, which could lead to long term deterioration in health (PDF 528KB)
MDA(NI)2009/018	09 Mar 09	Action Update	All Quickie Groove battery powered wheelchairs manufactured by Sunrise Medical / wheelchairs have not been fitted with a heavy duty transit kit or a restraining strap for the powered elevating leg rest. This strap allows the wheelchair to be used as a seat in a motor vehicle. In the event of a vehicle impact the wheelchair or leg rest could break loose, leading to injury to the wheelchair user or others (PDF 55KB)
MDA(NI)2009/017	04 Mar 09	Immediate Action	Staining solution for ophthalmic surgery. MembraneBlue© 0.5ml syringe manufactured by DORC International BV. The plunger may stick within the barrel of the syringe. This has led to the use of excessive force during injection of the solution, resulting in a sudden jet of liquid that can cause serious damage to intraocular tissues (PDF 68KB)
MDA(NI)2009/016	24 Feb 09	Action	Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International Limited. Potential for implanting incorrect anatomical components due to unclear labelling (PDF 57 KB)
MDA(NI)2009/015	24 Feb 09	Action	All Action 2000 manual wheelchairs manufactured by Invacare with serial numbers from 7007533957 to 7008568013 inclusive. The bolts used to secure the castor assemblies to the wheelchair frame can fail in use. This has caused occupants to fall from their wheelchair and sustain injuries (PDF 77KB)
MDA(NI)2009/014	23 Jan 09	Immediate action	UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems - Manufactured by MECALL Srl. The MHRA has received a report of the X-ray tube head falling onto the table after the support cable and the backup ‘safety device’ failed simultaneously. The tube head weighs 40 kg and there is a risk of death or serious patient injury if this failure occurs during examination (PDF 51KB)
MDA(NI)2009/013	18 Feb 09	Action	Unomedical Unilect 4831Q and 4841P short term adult and paediatric ECG monitoring electrodes.Degradation in performance after defibrillation. Following defibrillation the observed ECG waveform may show a 'flatline' (asystole). This may result in inappropriate treatment that could be detrimental to the patient (PDF 349KB)
MDA(NI)2009/012	18 Feb 09	Action	Aquarius haemofiltration machine. Software versions 4.01.11, 4.01.12 and 6.01. Manufactured by Edwards Lifesciences Ltd. This alert deals with two separate issues: Issue 1: The instructions in the operating manual describing the tubing set up and haemoperfusion filter choice are incorrect. Issue 2: It is possible to override fluid balance alarms. This can result in excess fluid remaining, or being removed, during therapy (PDF 415KB)
MDA(NI)2009/011	16 Feb 09	Immediate Action	Bacteriology culture medium.Chocolate agar + PolyViteX VCAT3 agar. Manufactured by BioMerieux Ltd. Reference no: 43611. Batch number: 826403401 / Risk of false negative results for Neisseria gonorrhoeae (N.gonorrhoeae), which may lead to misdiagnosis and potential missed treatment (PDF 206KB)
MDA(NI)2009/010	16 Feb 09	Action	All models of Jazzy, Quantum and LX battery powered wheelchairs manufactured by Pride Mobility Ltd / On some models of Jazzy, Quantum and LX powered wheelchairs the manufacturer has fitted tie down securement brackets (known as the Transit Securement Package – TSP) before delivery and has now issued updated instructions for use (PDF 449KB)
MDA(N()2009/009	12 Feb 09	Action	Blood collection tubes: Becton Dickinson (BD) Diagnostics Vacutainer® Serum tubes (16 x 100mm) red. Affected lots: 8015159, 8029093, 8059728, 8095550, 8113634 and 8161235 / When the above listed tubes are used with the BD reusable holder, or non-BD needle holders, there is the potential for the HemogardTM cap to come off, which may cause spillage and exposure to blood from open tubes (PDF 164KB)
MDA(NI)2009/008	5 Feb 09	Action	Ligating clips distributed by Teleflex Medical. Weck brand including Hem-o-lok, Horizon, Hemoclip Traditional and Hemoclip Plus. Holes have been detected in the tray of certain sterile packaged units, which may compromise the sterility of the product (PDF 37KB)
MDA(NI)2009/007	4 Feb 09	Immediate Action	EasiCath intermittent urinary catheters manufactured by Coloplast – recall of various models and batches. Some catheters have been caught in the welding of the packaging which has caused the catheter tip to be cut off or partly cut off, leaving a sharp edge. This would pose a risk of urethral injury if the user did not detect the sharp edges and tried to insert the catheter (PDF 30KB)
MDA(NI)2009/006	29 Jan 09	Immediate Action	Days Healthcare Ltd aluminium walking frames. All models with batch number E08/30. The adjustment spring clips in this batch of walking frames are faulty and can fracture. This has resulted in the frame legs collapsing, with the subsequent fall of the user (PDF 63KB)
MDA(NI)2009/005	28 Jan 09	Action	Colleague triple-channel mono volumetric infusion pumps with software version 5.09.92 and CXE pumps with software version 6.13.92. Unfamiliarity with the new method of programming the piggyback mode may lead to delays in treatment (PDF 299KB)
MDA(NI)2009/004	22 Jan 09	Action	Enteral feeding pump. Flocare Infinity pump model 35679 and Flocare Infinity Plus pump model 35680 manufactured by Nutricia. Specific serial numbers and software versions. Due to a software irregularity, pumps have the potential to deliver feed at a higher rate than that programmed. This may go undetected as the display shows the programmed rate not the actual rate. The manufacturer has issued an accelerated service programme to apply new software to the affected pumps (PDF 281KB)
MDA(NI)2009-003	19 Jan 09	Action	Sae-Flo MD extension set with Y-connector (lot number 80623/1 only).Manufacturer: Wescott Medical Ltd. Product code: EPCA200AY. A number of devices from this lot have been reported to leak at the connection between the anti-siphon valve (female Luer) and the tubing. Very few of the leaks were detected during priming. This can lead to inadequate pain relief or treatment of patients (PDF 42KB)
MDA(NI)2009-002	16 Jan 09	Action	All Folysil X-TRA indwelling urinary catheters manufactured by Coloplast, Mentor Medical or Porges – recall / The fluid in the prefilled syringe packed with thecatheter has not been sterilized. All healthcare and care workers who use these devices. Personnel involved in the purchase, supply and distribution of these devices.(PDF 29KB)
MDA(NI)2009/001	8 Jan 09	Action	All Medical Devices (PDF 35KB)