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NIAIC

Medical Device and Equipment Alerts (MDEA) Updates - 2007    

Number               
Issue Date                    
Level Of Urgency
Title
MDEA(NI)2007/113
20 Dec 07
Action
Volumetric Infusion Pump. Smiths Medical (Graseby ) 500 and 505volumetric infusion pumps - all models. There is the possibility of delivering an unintended 1.7ml bolus if the pump door is opened and then immediately closed following a stoppage of the pump (PDF 137 KB)
MDEA(NI)2007/112
18 Dec 07
Action
Enteral feeding pump. Fresenius Kabi Applix Smart Pump - -all models (PDF 241 KB)
MDEA(NI)2007/111
18 Dec 07
Immediate Action
Blood/soloution warming units. All Smiths Medical Level 1-31B air detector clamp (PDF 660 KB)
MDEA(NI)2007/110
18 Dec 07
Action
Infusion pump Schnider model used with Alaris PK pumps manufactured by Cardinal Health (PDF 524 KB)
MDEA(NI)2007/109
10 Dec 07
Action
Kimba Spring Paediatric Buggies Manufactured by Otto Bock (PDF 187 KB)
MDEA(NI)2007/108
7 Dec 07
Immediate Action
Robertshaw endobronchial tubes (rubber, disposable), all sizes. Manufactured by Pheonix Medical, a P3 Medical Ltd company.
There is a risk of cuff deflation due to a manufacturing design change.  Affected product codes and batch numbers are listed overleaf.  The manufacturer has now reverted to the original design.
P3 are not able to provide immediate replacement of all affected stock and are not aware of any alternative equivalent devices manufactured from natural rubber (PDF 519 KB)
MDEA(NI)2007/107
7 Dec 07
Immediate Action
External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 – 998. Manufactured by APC Medical Ltd.    Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off (PDF 121 KB)
MDEA(NI)2007/106
6 Dec 07
Action
Paediatric respiratory support device -Infant Flow® SiPAP™ manufactured by Viasys Healthcare. There has been an important change to the operator manual that needs to be communicated to end users (PDF 122 KB)
MDEA(NI)2007/105
6 Dec 07
Immediate Action
This alert has been replaced by MDEA(NI)2008/003 (PDF 914KB)
MDEA(NI)2007/104
6 Dec 07
Action
Procare Ltd / Wound drainage set for use in theatres: Privac pre-evacuated drainage set with 10ch drain and 600ml drainage bottle. Product code 24760. Batches 12032006 and 07052007 / Debris from the manufacturing and packaging processes has been found in the sterile packaging of some wound drainage sets from these batches. (PDF 120 KB)
MDEA(NI)2007/103
4 Dec 07
Action
Draeger Medical / Anaesthetic Gas Scavenging System (AGSS) receiver / Reports of anaesthetic scavenging hoses being misconnected to the blanked-off port of the Draeger AGSS receiver. This prevents gases from leaving the anaesthetic breathing system, creating excessive airway pressures, which if undetected could result in serious lung injury. (PDF 155 KB)
MDEA(NI)2007/102
4 Dec 07
Action
Intravenous (IV) infusion lines: all brands / Risk of back-tracking when more than one IV line is connected through a single access point. (PDF 126 KB)
MDEA(NI)2007/101
29 Nov 07
Action
Rubber / PVC gasket used to provide a weather proof seal on window and door openings (PDF 5 KB)
MDEA(NI)2007/100
29 Nov 07
Action
Window restrictors (PDF 5 KB)
MDEA(NI)2007/99
29 Nov 07
Action
LCD patient monitors on fixed mounts: risk of falling (PDF 5 KB)
MDEA(NI)2007/98
28 Nov 07
Action & Update
Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation: Inappropriate use, or modification, of cement composition leading to serious complication(an update) (PDF 5 KB)
MDEA(NI)2007/97
22 Nov 07
Action
Battery Charger for Powered wheelchair: Mentzer 24v 6A Konstant Charger Model G25-324-6 supplied by Exide, Sunrise Medical and Lomax mobility: The case temperature of the above charger, in normal use, is higher that the temperature requirements of BS EN 12182:1999, which specifies a maximum temperature of 41oC (PDF 133 KB)
MDEA(NI)2007/96
19 Nov 07
Action
Forth Medical Limited / Surgical tool bit/burr - Anspach cutting burrs with expiry dates from June 2008 to August 2011 (inclusive) / Possible breakdown of packaging leading to compromise of the sterile barrier (PDF 156 KB)
MDEA(NI)2007/95
7 Nov 07
Action
Automatic external defibrillator - Welch Allyn AED 20 (PDF 124 KB)
MDEA(NI)2007/94
05 Nov 07
Immediate Action /Information
Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system.
Catalogue number 8634111.
Lots: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809 and W07H1810.(PDF 128 KB)
MDEA(NI)2007/93
31 Oct 07
Immediate Action
General Ultrasound scanner: Nemio and Nemio XG Systems Manufactured by Toshiba Medical Systems Ltd (PDF 319 KB)
MDEA(NI)2007/92
30 Oct 07
Action
Counterfeit Durex Condoms / Counterfeit Durex Condoms have been placed on the UK market (PDF 163 KB)
MDEA(NI)2007/91
26 Oct 07
Action
Telecommunication Equipment - Unauthorised fraudulent access can be gained to telecommunication equipment which does not have adequate security controls in place (PDF 118 KB)
MDEA(NI)2007/90
26 Oct 07
Action
Grundy Heated food conveyors: Risk of exposure to Asbestos (PDF 514 KB)
MDEA(NI)2007/89
26 Oct 07
Action
Orthopeadic bone cement restrictor instrumentation. DePuy SmartSeal pressurisers - femoral and acetabular pressurisers (5pack) manufactured by DePuy CMW: Recall of SmartSeal pressuriser as the other pouch seal may be compromised (PDF 119 KB)
MDEA(NI)2007/88
25 Oct 07
Immediate Action & Information
EMS ventilator circuits, product code W196-002 manufactured by Galemed Corporation and supplied by Smiths Medical. These are breathing systems for use with Smiths Medical emergency and transport ventilators including: Parapac, Ventipac, Rescupac and Transpac models: A manufacturing problem has been identified where the valve in these breathing systems will not open, resulting in a blockage and potentially no oxygen being delivered to the patient. Galemed Corporation believes that this issue only affects three lot numbers of EMS ventilator circuits. These lot numbers are: 070528, 070620 and 070910 (PDF 132 KB)
MDEA(NI)2007/87
23 Oct 07
Immediate
BD Medical Surgical Systems Plastipak / 1ml, 2ml, 5ml and 10ml hypodermic Luer slip syringes manufactured between April 2007 and August 2007 / Multiple reports received of these syringes spontaneously disconnecting from, or failing to maintain a secure connection to, Luer fittings of other devices. (PDF 151KB)
MDEA(NI)2007/86
19 Oct 07
Immediate Action
Implantable Cardioverter defibrillator (ICD lead). Sprint Fidelis manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949: ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss pacing output, caused by fracture of the lead conductor (PDF 173 KB)
MDEA(NI)2007/85
16 Oct 07
Action
Boots NPI Healthcare / Home use blood glucose meters: Boots brand blood glucose monitoring system / Dropping or knocking the meter can cause display failure. (PDF 124 KB)
MDEA(NI)2007/84
12 Oct 07
Action
Curtain/bed screens risk of fire due to inadequate flame retardancy: some flame retardant cotton curtains/bed screens may exhibit poor flame retardancy, with resultant risk of fire (PDF 121 KB)
MDEA(NI)2007/83
9 Oct 07
Action
Curtain tracks and other fixed fittings in Emergency Admission Units - used as points of ligature (PDF 120 KB)
MDEA(NI)2007/82
4 Oct 07
Immediate Action
Bioresorbable screw: CALAXO interference screw implants manufactured by Smyth & Nephew Inc. Recall due to pre-tibial soft tissue swelling after implantation of CALAXO screws leading to the need for surgical intervention to remove any screw fragments (PDF 122 KB)
MDEA(NI)2007/81
19 Sep 07
Action
Invacare Action3 wheelchairs fitted with a manual ratchet recliner mechanism. Risk of injury to the user or carer from the sudden failure of the backrest ratchet. (PDF 121 KB)
MDEA(NI)2007/80
19 Sep 07
Action
Invacare Action 2000 wheelchairs (blue frame). Sudden detachment of the seat canvas allowing the user to fall. (PDF 128 KB)
MDEA(NI)2007/79
18 Sep 07
Immediate
Eschmann LTD / Electrosurgery bipolar unit: model TDB (serial numbers with the last six digits from 5D-1201 to 7D-1273 inclusive are affected - see appendix for full list) / Failure of a component in the main control board may lead to the power output being up to four times that displayed on front panel.(PDF 124 KB)
MDEA(NI)2007/78
12 Sep 07
Action
Kimberly-Clark NV/SA / Microcuff paediatric endotracheal tubes / Device may kink during use, which may impede or prevent ventilation (PDF 134 KB)
MDEA(NI)2007/77
11 Sep 07
Immediate
THIS HAS BEEN UPDATED BY MDEA(NI)2007-87 (PDF 152KB)
MDEA(NI)2007/76
7 Sep 07
Action
Sterile suction connecting tubing, ref number: UN30025FFM, manufactured by Universal Hospital Supplies Ltd: manufactured up to and including 14 November 2006, NHS Supply Chain code:FWP204: Due to an intermittent manufacturing fault there is a potential for the connectors on this tubing to be partially occluded resulting in ineffective suction. (PDF 667 KB)
MDEA(NI)2007/75
7 Sept 07
Action
Automatic external defibrillator: Lifepak 500 manufactured by Medtronic Ltd: Under certain conditions the defibrillator may deliver a shock at 100J instead of the manufacturer's minimum default setting of 200J. This problem affects defibrillators with operating software versions of 4.4 or lower. (PDF 2 MB)
MDEA(NI)2007/74
5 Sept 07
Immediate Action
Hip implants for hemiarthroplasty - Austin-Moore, F R Thompson and Thompson Modular endoprostheses manufactured by Biomet UK Ltd: Recall due to potential failure of sterile barrier packaging which could compromise product sterility. (PDF 508 KB)
MDEA(NI)2007/73
30 Aug 07
Immediate Action & Update
Hip resurfacing implants.: Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes). Inappropriate mixing of head and cup sizes due to incorrect labelling of the cups.The need for early revision due to loose joint fit as a result of mislabelled cups. (PDF 281 KB)
MDEA(NI)2007/72
23 Aug 07
Action
Vaginal specula: all single-use Cusco screw type vaginal specula manufactured by North Eos: All single-useCusco screw type specula supplied before 27 February 2007 have been wrongly labelled as sterile instead of clinically clean. Other models of vaginal specula from this manufacturer are not affected (PDF 147 KB)
MDEA(NI)2007/71
23 Aug 07
Immediate Action
Hospital beds: Hill-Rom TotalCare Duo 2: The manufacturer has omitted to provide suitable decontamination instructions with this pressure relieving hospital bed.The MHRA has received two reports of damaged mattress covers that allowed body fluids to soak into the mattress. No instruction was provided on how to check the condition of the mattress and cover. This presents a risk of cross infection.(PDF 143 KB)
MDEA(NI)2007/70
16 Aug 07
Immediate Action
Fluid warming set: Level1 normothermic IV fluid administration and irrigation sets - D/DI and IR/IRI series manufactured by Smiths Medical: Small holes have been found in the inner lumen (aluminium tube) of some sets which can allow leakage of the heating fluid into the infusate with the potential for contamination (PDF 498 KB)
MDEA(NI)2007/69
16 Aug 07
Immediate Action & Information
Hip resurfacing implants. Birmingham Hip resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd (see appendix for affected lot numbers). Inappropriate mixing of head and cup sizes due to incorrect labelling of the cups. The need for early revision due to loose joint fit as a result of mislabelled cups (PDF 279 KB)
MDEA(NI)2007/68
15 Aug 07
Immediate Action
Laryngoscope blades: Falcon single-use paediatric Miller blades size 00, 0 & 1, supplied by Draeger medical UK. Poor illumination of the airway and heating of the blade due to manufacturing problems with the bulb (PDF 702 KB)
MDEA(NI)2007/67
14 Aug 07
Immediate
Teleflex Medical / Oxygen humidifier: Hudson RCI large volume nebuliser, product code 41770 (see appendix for lot numbers) / potential for lower than the required oxygen concentration to be delivered due to a manufacturing fault. Manufacturer has recalled devices. (PDF 446 KB)
MDEA(NI)2007/66
8 Aug 07
Action
Abbott Nutrition / Enteral feeding pumps:ClearStar model number M771 / Risk of under-infusion due to cracking/breaking of internal adapter bracket. (PDF 344 KB)
MDEA(NI)2007/65
7 Aug 07
Action
HemoCue Ltd / Point of care blood glucose measurement systems:HemoCue Glucose 201 and HemoCue Glucose 201RT / Potential for false zero readins of blood glucose concentration. (PDF 128 KB)
MDEA(NI)2007/64
23 July 07
Action/Update
Roche Accu-Chek and Glucotrend: Abbott Diabetes Care FreeStyle - Point of Care and Home-use Blood Glucose Meters - Risk of overestimation of blood glucose results when these meters are used on samples from patients on treatments that contain maltose,xylose or galactose. (PDF 125 KB)
MDEA(NI)2007/63
03 July 07
Immediate
ConMed Corporation / Eliminator esophageal PET balloon dilator and pyloric/colonic PET balloon dilator / Various labelling errors and inconsistencies have been identified, which can result in the use of an incorrect balloon size. (PDF 129 KB)
MDEA(NI)2007/62
28 June 07
Action
Profiling bed: Invacare Scanbed 750 (SB 750) with integral bed rails : Risk of asphyxiation to children from the potential for entrapment between the wooden bed rails  (PDF 143 KB)
MDEA(NI)2007/61
22 June 07
Action
Cubical curtain track rails (anti ligature): Installation issues with anti ligature cubical curtain track rails  (PDF 164 KB)
MDEA(NI)2007/60
21 June 07
Action
TK3 Control Potentiometer (Lighting dimmer): Overheating due to terminal over tightening or forcing unit into back box (PDF 2 MB)
MDEA(NI)2007/59
19 June 07
Action
Advanced Medical Optics (AMO) / Contact lens solution: COMPLETE MoisturePLUS / worldwide product recall - this product is associated with an increased incidence of Acanthamoeba keratitis  (PDF 131 KB)
MDEA(NI)2007/58
14 June 07
Action & Information
Total Hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal on metal articulation: Unexplained groin pain and the need for early revision due to periprosthetic soft tissue necrosis. (PDF 763 KB)
MDEA(NI)2007/57
13 June 07
Action
IV extension lines: model 6222 range of V-Green narrow bore extension lines manufactured by Vygon (UK) Ltd: There is a potential for the female connector of the line to crack when used to deliver propofol (an intravenous anaesthetic agent). This may result in leakage of this drug and failure to induce and maintain general anaesthesia. The manufacturer has initiated a recall of specific batch numbers irrespective of the drugs they are being used with. (PDF 124 KB)
MDEA(NI)2007/56
12 June 07
Immediate Action
Pregnancy test kits: Clearview HCG, product code 500158, lot number HG0050: Possibility of false negative pregnancy test results. (PDF 299 KB)
MDEA(NI)2007/55
12 June 07
Action
All brands of needle free intravascular connectors: The instructions of several brands of these devices have changed significantly in the last two years. (PDF 127 KB)
MDEA(NI)2007/54
12 June 07
Action
Electrical Extension Lead (multiple socket outlets): Failure of electrical supply to equipment, including overheating which may lead to fire and possible loss of lives. (PDF 220 KB)
MDEA(NI)2007/53
12 June 07
Action
Single-use capillary blood sampling device: Microtainer Safety Flow Lancets manufactured by BD Preanalytical Systems. Product code 366354, 366355 and 366358. Potential for a sharps injury to patient or user as the blade may become loose and then separate from the main body on activation of the device. The manufacturer has recalled the affected lot numbers of these products. (PDF 127 KB)
MDEA(NI)2007/52
12 June 07
Action
Homecraft Rolyan bath lift hand controls for the Bathmaster 2000, Bathmaster Classic, Bathmaster Xtra and Bathmaster Reclina: The lack of vent holes or the blocking of vent holes in the hand control casing can lead to a build up of battery gases, causing the case to split, which can result in injury to the operators hand. (PDF 185 KB)
MDEA(NI)2007/51
6 June 07
Action
Devices for securing lines, tubes and drains: Drain-Fix 680M and 685M; Central-Gard 667M and 668M; Epi-Fix 670M. All manufactured by Unomedical Ltd. A packaging problem that may affect one in six of the manufactured peel pouches, which may compromise the sterility of the devices. Therefore the manufacturer is recalling all affected batches.(PDF 122 KB)
MDEA(NI)2007/50
5 June 07
Action
External defibrillators batteries for Lifepak 20 manufactured by Medtronic. Some Lifepak 20 defibrillators have been fitted with batteries that may have a reduced capacity. Some of the affected batteries have also been sold separately. (PDF 124 KB)
MDEA(NI)2007/49
5 June 07
Action
Laryngoscope handle: Optima XL stubby handle, manufactured by Timesco of London Ltd. Poor contact between Timesco stubby handles and Timesco laryngoscope blades, which may result in the bulb not being lit with subsequent delays to intubation.(PDF 137 KB)
MDEA(NI)2007/48
31 May 07
Immediate Action
Medication cassette reservoir for CADD legacy infusion pumps manufactured by Smiths Medical: model numbers 21-7001-24 and 21-7002-24. In certain batches of medication reservoirs there was a change of material formulation, to include calcium carbonate. There have been reports of shifts in pH of medication, discolouration and occlusions, which may or may not be related to this change  (PDF 129 KB)
MDEA(NI)2007/47
31 May 07
Action
Invacare Flamingo mobile patient hoists: Detachment of spreader bar from hoist whilst in use.(PDF 191 KB)
MDEA(NI)2007/46
31 May 07
Action
Boc Medical Gas Outlet Mark IV Valve Plate: No Automatic Isolation Of Medical Gas Supply (PDF 120 KB)
MDEA(NI)2007/45
24 May 07
Action
External pacemakers and temporary cardiac pacing leads. Potential for loss of pacing due to accidental disconnection of temporary pacing leads and lead adaptors (PDF 124 KB)
MDEA(NI)2007/44
24 May 07
Action
Primus anaesthetic workstation supplied by Draeger Medical UK Ltd. potential misconnection of the backup oxygen cylinder (PDF 125 KB)
MDEA(NI)2007/43
22 May 07
Action
This alert has been replaced by MDEA(NI))2007/52  (PDF 182 KB)
MDEA(NI)2007/42
22 May 07
Immediate
BARIATRIC PROFILING BEDS - NIGHTINGALE PRO AXIS AND PRO AXIS PLUS: Ignition of flammable gases from an overcharged battery within the main control box can result in the metal cover being blown off, putting those in the vicinity at risk of injury (PDF 129 KB)
MDEA(NI)2007/41
22 May 07
Immediate.
All Paediatric Ventilator Breathing Systems Containing a water Trap, Manufactured by VIASYS Healthcare: The MHRA has received reports of VIASYS Auto Drain Water Traps Failing to Drain Accumulated Fluid  (PDF 127 KB)
MDEA(NI)2007/40
17 May 07
Action
Urine Test Strips: Makromed - all products with expiry dates in 2007 or 2008. Potential for misdiagnosis due to false negative results when testing for blood or ketones in urine (PDF 551 KB)
MDEA(NI)2007/39
10 May 07
Action
Flexible Endoscopes manufactured by Olympus, distributed in UK by KeyMed Limited: The outer sheath and light guide tube of Olympus flexible endoscopes may be damaged by direct exposure to ultraviolet (UV) light, as used in some endoscope storage and drying cabinets  (PDF 147 KB)
MDEA(NI)2007/38
2 May 07
Action
Plastic two-part self-assembly Step/Kick stools (PDF 246 KB)
MDEA(NI)2007/37
2 May 07
Action
IV Cannuals used in conjunction with automatic powered injectors (PDF 121 KB)
MDEA(NI)2007/36
26 April 07
Action
UMBILICAL CORDCLAMP CLIPPER MANUFACTURED BY UNOMEDICAL LTD: There is potential for the bald to fall out of the product or break during use of identified lots (PDF 128 KB)
MDEA(NI)2007/35
26 April 07
Immediate Action
POINT OF CARE BLOOD GLUCOSE MEASUREMENT SYSTEMS: HEMOCUE: Potential for unreliable blood glucose readings when testing samples from pre-term neonates  (PDF 306 KB)
MDEA(NI)2007/34  
26 April 07
Action & Update
PATIENT HOISTS & SLINGS: Falls due to the poor compatibility of slings and hoists, inappropriate laundering of slings and inadequate maintenance of patient hoists used in hospitals and the community(PDF 122 KB)
MDEA(NI)2007/33
19 Apr 07
Action
STOBU Steam stop valve - Sudden failure of the thread in the bush of the valve spindle resulting in valve opening violently whilst under steam pressure on a boiler (PDF 172 KB)
MDEA(NI)2007/32
19 Apr 07
Action
Helicopter Landing Sites - Loose Debris impacting upon the helicopter (PDF 120 KB)
MDEA(NI)2007/31
4 Apr 07
Action
External Defibrillator: Lifepak 20 Defibrillator manufactured by Medtronic. Some Lifepak 20 defibrillators may fail to deliver therapy. Once mains power is disconnected the defibrillators may not turn on with battery power. The display is blank and all indicator lights are off.(PDF 230 KB)
MDEA(NI)2007/30
29 Mar 07
Action
Retrievable permanent inferior vena cava (IVC) filters: Complications associated with filter retrieval  (PDF 122  KB)
MDEA(NI)2007/29
22 Mar 07
Immediate
INTAVENT ORTHOFIX LTD / reusable flexible laryngeal mask airway size 2.5, model codes 7125R AND 7125DR / risk of tube kinking in the proximity of the connector, which could lead to the obstruction of airflow to the patient.(PDF 155 KB)
MDEA(NI)2007/28
22 Mar 07
Immediate
GAMBRO / HAEMODIALYSIS MACHINE: INTEGRA / events of insufficient fluid removal have been recorded during ultrafiltration (PDF 150 KB)
MDEA(NI)2007/27
22 Mar 07
Action
GE HEALTHCARE / Patient Monitoring System: APEXPRO/APEXPRO CH Telemetry System / possibility of no visual or audible system failure alarms.(PDF 161 KB)
MDEA(NI)2007/26
21 Mar 07
Immediate Action
EXTERNAL DEFIBRILLATORS: SAMARITAN AED MANUFACTURED BY HEARTSINE: MODELS SAM001, SAM002 AND SAM003. In semi-automatic mode the device incorrectly recognises an unusual ECG rhythm. The rhythm is non-shockable but the device can advise to shock. The manufacturer has advised users not to use these devices in automatic modes until the software has been updated. A copy of the manufacturer’s advisory notice is on the field safety notice section of the MHRA website.(PDF 143 KB)
MDEA(NI)2007/25
16 Mar 07
Immediate Action
Update All QUATTROcare spray cans manufactured prior to 5 March 2007, for use in KaVo QUATTROcare dental handpiece maintenance systems. KaVo Dental Ltd have recalled all their QUATTROcare spray cans due to a risk of fire/explosion. QUATTROcare Cans may leak flammable gases when attached to a QUATTROcare maintenance system. (PDF 174 KB)
MDEA(NI)2007/24
16 Mar 07
Action
Boston Scientific Ltd. Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families. Delay in delivery of therapy during device middle of life phase due to temporarily extended charge time limits. Transition to device end of life (EOL) without prior observation of elective replacement indication (ERI) even though battery capacity remains available (PDF 164 KB)
MDEA(NI)2007/23
14 Mar 07  
Action
Single use capillary blood sampling device: Unitika 3 Normal, Unitika 3 Comfort and Unistik 3 Neonatal & Laboratory devices. Manufactured by Owen Mumford. Potential for needlestick injury to users and damage to patients sampling site due to a manufacturing fault. (PDF 148 KB)
MDEA(NI)2007/22
14 Mar 07  
Action
Callisto Macintosh size 3 (adult) single-use laryngoscope blade, manufactured by Timesco of London Ltd: the fibreoptic core may break and separate from the blade. The manufacturer has initiated a recall of all affected product  (PDF 156 KB)
MDEA(NI)2007/21
9 Mar 07
Immediate
UNIPATH LTD / COAGULATION POINT OF CARE TEST:CLEARVIEW SIMPLIFY D-DIMER. Kit lot numbers PT030A and PT031A containing test devices of batch number 682-024 / Increased risk of false negative results  (PDF 507 KB)
MDEA(NI)2007/20
20 Feb 07
Action
CONMED CORPORATION / GRASPING FORCEPS - CONMED DETACHA TIP ENDOSCOPIC multiple use grasper and disposible hand held graspers and dissectors (ratcheted and non-ratcheted) / tips of devices manufactured between 25/8/2003 AD 24/3/2005 may be susceptible to breaking (PDF 696 KB)
MDEA(NI)2007/19
15 Feb 07
Immediate
DRAEGER UK Limited / Patient Vital Signs Monitor: DRAEGER Infinity Monitor with Infinity Docking Station (IDS) / The Infinity Docking Station Mechanism may fail on all models of Infinity Monitors. This can result in the monitor falling from its mounting.(PDF 178 KB)
MDEA(NI)2007/18
13 Feb 07
Action
INVACARE Ltd / Patient Hoists: INVACARE C800 series ceiling track / risk of injury resulting from falls due to failures of the motor drive in C800 series hoists manufactured between December (PDF 152 KB)
MDEA(NI)2007/17
13 Feb 07
Action
SMITHS Medical International Ltd / Fluid Warming Administration Set: SMITHS Medical Level 1 Normothermic IV Fluid Administration Set. Catalogue number DI-60HL / manufacturing fault in the administration set can prevent appropriate warming of the blood/fluid to be administered, leading to a delay in patient treatment. (PDF 151 KB)
MDEA(NI)2007/16
8 Feb 07
Action
Laundry damage to patient lifting slings with rigid clips: failure during use  (PDF 800 KB)
MDEA(NI)2007/15
8 Feb 07
Action
Electric lifting aids with mechanical anti crush protection:Risk of patient fall/trauma (PDF 142 KB)
MDEA(NI)2007/14
8 Feb 07
Action
Fisher and Paykel Healthcare re-usable CPAP respiratory masks and connectors for obstructive sleep apnoea: Plastic tabs incorporated into the re-usable CPAP mask connectors may break off when in use with the possibility of components entering the patient’s airways. The affected connectors are found in most Fisher and Paykel CPAP face, nasal and oral mask kits, and various tubing kits. Fisher and Paykel have now redesigned this connector (available since April 2006) and are recalling all face mask kits with the previous version; the recall notice and fax back form are appended to this alert  (PDF 231 KB)
MDEA(NI)2007/13
7 Feb 07
Action
Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd: The MHRA has received reports of inadequate ventilation in non-intubated patients, thoracic cage and lung damage and raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply (PDF 178 KB)
MDEA(NI)2007/12
7 Feb 07
Action & Information Request
MDEA(NI)2007/11
7 Feb 07
Immediate Action & Update
MDEA(NI)2007/10
5 Feb 07
Action
BAXTER CONTINU-FLO Solution Sets With Check Valve. Affected Product Codes: EMC 9603, RMC 9603, RMC 9604, RMC 9619 / During secondary infusions there is the potential for solution from the secondary infusion container to pass through the check valve (one-way valve). Backflow can result in inadequate treatment by causing an under-infusion of the secondary infusion (PDF 169 KB)
MDEA(NI)2007/09
1 Feb 07
Action
Bed and grab rails: bed rails can successfully prevent falls, but their incorrect use has resulted in the deaths of bed occupants by asphyxiation due to entrapment (PDF 143 KB)
MDEA(NI)2007/08
1 Feb 07
Action
NEONATAL RADIANT WARMER: DRAEGER RESUSCITAIRE, Model RW82VHA-1C with variable height adjustment: screws that secure the column to the base may loosen over time, allowing the support column to tilt, due to incorrect fitting (PDF 142 KB)
MDEA(NI)2007/07
25 Jan 07
Immediate Action
BOC Ltd, AZ size aluminium medical oxygen cylinders fitted with a key operated pin index valve for use in MRI units: The MHRA has received two reports of AZ aluminium oxygen cylinders fitted with obsolete pin index valves. These obsolete valves contain a metal component that is sufficiently magnetic to make the cylinder potentially hazardous when used in an MRI Environment  (PDF208 KB)
MDEA(NI)2007/06
23 Jan 07
Action
Smiths Medical - Chest Drain: Portex chest drainage system with adjustable straw. Product code 200/870/000, lot number 489962 - Failure to create a seal when the system is connected to the chest drainage bottle leaving the patient at risk of a pneumothorax. The manufacturer is recalling one lot of this device  (PDF 142 KB)
MDEA(NI)2007/05
17 Jan 07
Immediate Action
Inditherm OTM1, OTM2, GTM1, RB1 and OTB1 operating theatre blankets and mattresses, used for maintaining patients body temperature: repeated folding of these devices can cause internal damage to the heating element. (PDF 142 KB)
MDEA(NI)2007/04
17 Jan 07
Action
Vygon (UK) Ltd paediatric IV bacterial filter with extension line, product code 0807.205: Cracking of the green hub on the filter has resulted in leakage. The manufacturer has recalled specific batches. (PDF 147 KB)
MDEA(NI)2007/03
12 Jan 07
Action
Ferno Falcon Six and Hawk Six ambulance stretcher trolleys: Weld failure of the foot end lock bracket (PDF 194 KB)
MDEA(NI)2007/02
9 Jan 07
Action
Patient Monitoring System - Philips Medical Systems Multi Measurement Server (MMS) Model: M3001A and SpO2 Module M1020B: The pulse oximeter channel of the MMS or the SpO2 module in these monitors when used with disposable SpO2 transducers/probes may display a 100% saturation when the transducer is not attached to a patient. Should this happen in the case of a hypoxic patient, no alarm will be given  (PDF 445 KB)
MDEA(NI)2007/01
02 Jan 07
Action
Reporting Adverse Incidents and Disseminating Medical Device/Equipment Alerts  (PDF 81 KB)
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