NIAIC

Medical Device and Equipment Alerts (MDEA) Updates - 2005

Number	Issue Date	Level Of Urgency	Title
MDEA(NI)2005/95	23-Dec-05	Action	Medtronic Sigma implantable pacemakers: Failure of interconnecting wires within the pacemakers leading to a number of different problems (PDF 216 KB) List of affected serial numbers (PDF 60 KB)
MDEA(NI)2005/94	21-Dec-05	Immediate Action & Update	Baxter Colleague volumetric infusion pumps: all models - Colleague pump batteries may become damaged due to excessive discharge (completely run down) (PDF 116 KB)
MDEA(NI)2005/93	20-Dec-05	Action	Guidant INSIGNIA and NEXUS implantable pacemakers: Recall due to component failure (PDF 185KB) List of affected serial Numbers (PDF 248 KB)
MDEA(NI)2005 92	15-Dec-05	Action	ALARIS (IVAC) P Series Pumps with Fiamm Sealed Lead Acid Batteries - Fiamm Batteries in P Series can prematurely lose capacity during the first and second years of operation (PDF 149 KB)
MDEA(NI)2005/91	14 Dec 05	Action	Blood pressure monitors and sphygmomanometers - The Committee on Blood Pressure Monitoring in Clinical Practice was established by the Chief Medical Officer to address concerns regarding the use of mercury sphygmomanometers and the accuracy of alternatives (PDF 142 KB) Report of the Independent Advisory Group on Blood Pressure Monitoring in Clinical Practice (PDF 43 KB)
MDEA(NI)2005 90	12-Dec-05	Action	Guidant INSIGNIA and NEXUS implantable pacemakers - Device may exhibit intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry, reversion to ventricular inhibited pacing (VVI) and/or a reset warning message upon interrogation (PDF 209 KB)
MDEA(NI)2005 89	7-Dec-05	Immediate Action	Gambro Prisma Haemodialysis Sets: Prisma M100 Pre Set lot numbers: 05F1574, 05F2387G, 05G1366G, Prisma HF1000 Pre Set lot number: 05F0864P: During disconnection of the Prisma set from the Prisma haemodialysis system, blood can spurt out from the access pressure pod (PDF 161 KB)
MDEA(NI)2005 88	6-Dec-05	Action	VIASYS Infant Nasal CPAP breathing circuits model numbers CG8182 and CG8150 used with infant flow VIASYS SiPAP driver. - Risk of heater wire fitting detaching from the breathing circuit on certain batch numbers, resulting in pressure loss and discontinuation of oxygen therapy (PDF 141 KB)
MDEA(NI)2005 87	29-Nov-05	Information	Self Adhesive Monitoring/Diagnostic Electrodes: Risk of Injury Removal - May cause skin injuries upon removal(PDF 137 KB)
MDEA(NI)2005 86	29-Nov-05	Information MRI	MRI Compatible ECG Cables and electrodes: Risk of patient burns to the skin if there is less than optimal contact between the skin and the electrodes (PDF 138 KB)
MDEA(NI)2005/85	29 Nov 05	Action	ELA Medical implantable pacemaker models: Device Family, Symphony, Rhapsody - Model Numbers - DR 2550 and SR2250.DR+2530,DR2510, D2410 and SR2210 - Potential for loss of pacing output and telemetry without warning (PDF 242KB)
MDEA(NI)2005/84	28 Nov 05	Immediate Action	Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices - Devices are intended for self-use by one patient only, to take blood samples for self-monitoring. The use of Softclix lancing devices by healthcare and care workers to take blood samples from multiple patients has been implicated in the transmission of hepatitis B between patients (PDF 173KB)
MDEA(NI)2005-83	21 Nov 05	Action	Air-filled mattress overlays: Risk of patients falling from bed (PDF 83KB)
MDEA(NI)2005 82	18-Nov-05	Immediate Action & Update	Automated endoscope reprocessors: Risk of failure to decontaminate auxiliary channels (PDF 143 KB)
MDEA(NI)2005 81	17-Nov-05	Information	ABB Cables - 35mm2 3-phase split concentric service cable was found to have no insulation on the grey phase conductor for a length of approximately 2m. Black PVC bedding tape was missing intermittently in the area of the defect (PDF 136KB)
MDEA(NI)2005 80	8-Nov-05	Immediate Action & Update	All anaesthetic breathing systems - Entrapment of anaesthetic breathing systems between the operating table and patient transfer trolley (PDF 173 KB)
MDEA(NI)2005 79	7-Nov-05	Immediate Action	Conmed and Valleylab: Footswitches for use with electrosurgical units (ESUs) - manufacturers share the same type of footswitch connector but are wired differently. If the footswitches intended for one type of ESU are used with the other, the ESU will deliver 'cut' waveforms when the 'coagulate' footswitch is depressed, or vice versa (PDF 100 KB)
MDEA(NI)2005 78	4-Nov-05	Immediate Action	Medtronic LIFEPAK 12 defibrillator/monitor series: QUIK-COMBO cables and standard (hard) paddles: The pins in the connectors of cables and paddles can fatigue and break with potential for a loss of external pacing and defibrillation functions (PDF 140 KB)
MDEA(NI)2005 77	4-Nov-05	Action - Information Request	Astra Tech Ltd Exudrain, Exudrain Mini and Abdovac vacuum wound drains - Potential for leakage between the bulb and the exit connector (PDF 102 KB)
MDEA(NI)2005 76	27-Oct-05	Action	Spacelabs 5 Lead ECG Cable: Part Number 012-012301 Batch Numbers 31942, 34956, 35209, 35296, 35747, 36239 and 36555 - The yellow (left arm) and green (left leg) leads of some batches of their 5 lead ECG cable, part number 012-0123-01 have been cross connected (PDF 363 KB)
MDEA(NI)2005 75	26-Oct-05	Action	Intersurgical adult oxygen mask with ear loops: model number 1104001 and lot number 3055625: Intersurgical has initiated a recall of their oxygen mask with ear loops due to a manufacturing problem that has caused a blockage in the oxygen ports (PDF 334 KB)
MDEA(NI)2005 74	26-Oct-05	Action	GE Corometrics/Marquette 170 series fetal monitors, cardiotocography - Electrical interference from the external power supply can be displayed as a valid fetal heart rate (FHR) (PDF 889 KB)
MDEA(NI)2005 73	19-Oct-05	Action	Nellcor N-595 pulse oximeters N-395, NPB-290 AND NPB-295 pulse oximeters (with serial numbers after G01844386) - The failure rate of the loud speaker component is higher than expected, This may result in the monitor losing its audio alarm (PDF 107 KB)
MDEA(NI)2005 72	19-Oct-05	Action	Natural Gas Supply Distribution Pipework - Underground natural gas supply pipe ruptured during construction excavations (PDF 82 KB)
MDEA(NI)2005 71	14-Oct-05	Immediate Action	bms Critical Care extension sets: part numbers 25-7200 and 25-7150 - Fluid leakage through Luer connector (PDF 96 KB)
MDEA(NI)2005 70	12-Oct-05	Immediate Action	Operating Theatre patient transfer systems - Possible risk of entrapment of Patient Breathing Circuits during patient transfer into or out of the Operating Theatre (PDF 95 KB)
MDEA(NI)2005 69	11-Oct-05	Action	Central venous catheter and pacing lead inducer kits - Misuse of guidewire straighteners; potential for venous embolisation (PDF 94 KB)
MDEA(NI)2005 68	22-Sep-05	Immediate action	Johnson & Johnson Wound Management Sterile Ray-Tec X-Ray Detectable Swabs - recall - A packaging defect means that the sterility of the swabs and the packaging may have been compromised (PDF 369 KB)
MDEA(NI)2005 67	15-Sep-05	Action	TRDS Food Trolley - Control Panel Fire (PDF 92 KB)
MDEA(NI)2005 66	08-Sep-05	Action	All biomedical test kits for the identification of Neisseria gonorrhoea (N. gonorrhoea) - Increased risk of false negative or ambiguous results (PDF 372 KB)
MDEA(NI)2005 65	31Aug-05	Action	Baxter Healthcare Colleague volumetric infusion pumps product code 2M8151K, FKM8151 and 2M8153K - Recall - Due to a problem with a clocking circuit, the internal communications in some Colleague pumps can be disrupted (PDF 334 KB)
MDEA(NI)2005 64	17 Aug 05	Immediate Action	Portex uncuffed blue line tracheostomy tubes of model number 100/506/040 and batch number 447302- A number of 3mm tracheostomy tubes have been incorrectly packaged and labelled as 4mm tubes (PDF 343 KB)
MDEA(NI)2005 63	17 Aug 05	Action	Mobile Heated Food Trolley - Damage to electrical power plug with consequential electric shock injury (PDF 335 KB)
MDEA(NI)2005 62	16-Aug-05	Action	Automatic Temperature Controllers in Vaccine Chill Stores - Inappropriate temperature/compressor controller settings (PDF 348 KB)
MDEA(NI)2005 61	12-Aug-05	Immediate Action	Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) - Guidant has revised programming recommendations to reduce risk of a software error that can potentially cause loss of cardioversion, defibrillation, telemetry and programmability (PDF 348 KB)
MDEA(NI)2005 60	10-Aug-05	Immediate Action	Guidant implantable pacemaker models: PULSAR, PULSAR MAX, PULSAR MAX II, DISCOVERY, DISCOVERY II, MERIDIAN, CONTAK TR, manufactured between 25 November 1997 and 26 October 2000 - Failure of a hermetic seal, potentially leading to a number of problems (PDF 343 KB) List of affected serial numbers (PDF 90 KB)
MDEA(NI)2005 59	10-Aug-05	Action	Automatic Ice-making Equipment - Possible contamination (PDF 321 KB)
MDEA(NI)2005 58	27-Jul-05	Immediate Action	ELA Medical Alto implantable cardioverter defibrillator (ICD), models: 614, 615, 617, 624, 625 and 627 - Recall due to premature battery depletion and/or prolonged charge time, leading to loss of cardioversion, defibrillation or pacing (PDF 56 KB)
MDEA(NI)2005 57	26-Jul-05	Action	St Jude Medical implantable cardioverter defibrillators (ICDs - Potential for a reduction in number of shocks and inappropriate rate responsive pacing (PDF 351 KB)
MDEA(NI)2005 56	20-Jul-05	Action	CMS Dental, Soft-Core endodontic obturators (root canal obturation devices) - Reduced radiopacity (PDF 334 KB)
MDEA(NI)2005 55	14-Jul-05	Action	Styrene polymer based surgical and examination gloves - various manufacturers - Some gloves degrade and may disintegrate when in contact with certain solvents, for example acetone, which is present in products such as spray on wound dressings (PDF 323 KB)
MDEA(NI)2005 54	14-Jul-05	Immediate Action - Update	SLE Ltd disposable heated patient circuit N2188 and N5188 variants used with the SLE2000, 2000HFO and 5000 neonatal and infant ventilators - Blockage in a connector in the ventilator circuit due to a manufacturing problem in 14 batches. SLE has initiated an extended recall (PDF 107 KB)
MDEA(NI)2005 53	08-Jul-05	Action	Crib Trolleys with drop-shelves - Risk of collapse while bathing infants (PDF 189 KB)
MDEA(NI)2005 52	01-Jul-05	Immediate Action	Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) - Recall due to component failure resulting in potential loss of cardioversion, defibrillation and reduced device longevity (PDF 95 KB)
MDEA(NI)2005 51	29-Jun-05	Immediate Action	SLE Ltd disposable heated patient circuit N2188 and N5188 variants used with the SLE2000, 2000HFO and 5000HFO neonatal and infant ventilators - Blockage in a connector in the ventilator circuit, due to a manufacturing problem in four batches. SLE Ltd has initiated a recall (PDF 387 KB)
MDEA(NI)2005 50	29-Jun-05	Action	Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) - specific AVT models - Software error potentially causing loss of cardioversion, defibrillation, telemetry and programmability (PDF 110 KB)
MDEA(NI)2005 49	26-Jun-05	Action	Guidant CONTAK RENEWAL (model H135) and CONTAK RENEWAL 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds) - Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage (PDF 112 KB)
MDEA(NI)2005 48	29-Jun-05	Action	Guidant VENTAK PRIZM 2DR implantable cardioverter defibrillator (ICD) model No 1861 - Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock (PDF 120 KB)
MDEA(NI)2005 47	24-Jun-05	Action	Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay - False results may be observed when using this combination of assay and laboratory analyser (PDF 95 KB)
MDEA(NI)2005 46	23-Jun-05	Action	Suction systems including suction tubing, collection jar/canister and suction controller - Misassembly of suction systems leading to failure during emergency use (PDF 95 KB)
MDEA(NI)2005 45	23-Jun-05	Action	Electrically operated beds - Risk of entrapment and crushing from accidental operation of foot controls (PDF 95 KB)
MDEA(NI)2005 44	22-Jun-05	Action	Medisense Optium Xceed, Therasense FreeStyle Mini and Therasense FreeStyle blood glucose meters - The units of measurement displayed may inadvertently be changed by the user from mmol/l to mg/dl. The meter user may therefore think that the blood glucose level is too high (PDF 95 KB)
MDEA(NI)2005 43	21-Jun-05	Action	Alcohol Based Hand Wash (PDF 104 KB)
MDEA(NI)2005 42	16-Jun-05	Action	Defibrillator - Laerdal adaptor cable, product code 920650 - Failure of Laerdal adaptor cable may prevent operation of defibrillator (PDF 464 KB)
MDEA(NI)2005 41	16-Jun-05	Action	Laryngoscopes - Incorrect assembly of laryngoscopes (PDF 715 KB)
MDEA(NI)2005 40	13-Jun-05	Immediate Action	Pharmacy Refrigerator Model PE 902 and PG 902 - Control setting not locked (PDF 398 KB)
MDEA(NI)2005 39	06-Jun-05	Action	Minor surgery cautery probes - Failure to decontaminate cautery probes correctly may result in increased risk of cross-infection (PDF 396 KB)
MDEA(NI)2005 38	06-Jun-05	Information	Blood lines for renal dialysis equipment - Incorrect fitting of blood lines of renal dialysis equipment may lead to adverse effects on patient health (PDF 387 KB)
MDEA(NI)2005 37	31-May-05	Information	Infrared personal attack alarm systems - Systems may not function correctly due to interference from high frequency fluorescent light fittings (PDF 395 KB)
MDEA(NI)2005 36	20-May-05	Action	Sunrise Medical Ltd - Coopers Cumfy elbow crutch, product code 8353C - A manufacturing fault has affected the strength of elbow crutches, putting users at risk. Sunrise Medical Ltd is recalling a particular batch of affected crutches (PDF 446 KB)
MDEA(NI)2005 35	18-May-05	Action	All brands of needle free intra-vascular connectors - The instructions for use of many brands of needle free connectors have undergone significant changes, in particular to the maximum period of use of the device (PDF 387 KB)
MDEA(NI)2005 34	18-May-05	Action	Counterfeit Dentsply Spectrum TPH (Dental restoration filling composite) - Counterfeit dental filling material compules have been illegally placed on the UK market (PDF 628 KB)
MDEA(NI)2005 33	11-May-05	Action Immediate	BD Medical 25 gauge spinal needles - Leakage associated with the plastic hub of the needle leading to risk of under-infusion. The manufacturer has initiated a recall of certain lots (PDF 394 KB)
MDEA(NI)2005 32	10-May-05	Action	Heat patches or heat packs intended for pain relief - Risk of burns (PDF 384 KB)
MDEA(NI)2005 31	04-Mar-05	Action	LifeScan OneTouch Ultra, LifeScan InDuo and LifeScan PocketScan blood glucose meters - The units of measurement displayed may inadvertently be changed from mmol/l to mg/dl, resulting in the meter user thinking that the blood glucose level is too high(PDF 393 KB)
MDEA(NI)2005 30	21-Apr-05	Action	Posture belts fitted to wheelchairs and seating - Incorrectly fitted or adjusted posture belt attached to a wheelchair can lead to death or serious injury to a wheelchair user (PDF 391 KB)
MDEA(NI)2005 29	19-Apr-05	Action	Mobile electric patient hoists - various manufacturers - Potential for electric actuators to fail without warning, causing sudden dropping of the hoist boom, leading to serious injury of the patient and/or carer (PDF 636 KB)
MDEA(NI)2005 28	31-Mar-05	Immediate Action	Intersurgical adult circle breathing systems Ref 2000 Lot 1050218, Ref 2010 Lot 1050139 and Ref 2002 Lot 1050085 - Recall of Intersurgical adult circle breathing systems due to potential risk of microbial contamination (PDF 495 KB)
MDEA(NI)2005 27	30-Mar-05	Action	Rocket Medical - chest drainage tubing set, model code R54.502 - Risk of pneumothorax due to the possible detachment of the tube, which forms the underwater seal in the chest drainage bottle. The manufacturer is recalling devices, which were manufactured between October 2003 and May 2004 (PDF 391 KB)
MDEA(NI)2005 26	30-Mar-05	Action	Prosan Flexi-T 300 intrauterine devices - batch 01A1 - Detachment of control threads (PDF 540 KB)
MDEA(NI)2005 25	25-Mar-05	Immediate Action	Medtronic LIFEPAK 500 monophasic automated external defibrillator manufactured from March to May 1997 - With the electrodes properly connected, the device may continue to display a 'connect electrodes' message and may not analyse the patient's heart rhythm. This could delay or prevent resuscitation (PDF 392 KB)
MDEA(NI)2005 24	18-Mar-05	Immediate Action	Implantable drug pumps - Potential patient harm and/or damage to implantable drug pumps, from drug solutions incorporating defective saline for injection (abnormally high pH) (PDF 134 KB)
MDEA(NI)2005 23	18-Mar-05	Action Update	Medtronic implantable cardioverter defibrillator (ICD) - various models - Battery defect; possible rapid depletion without warning (PDF 106 KB)
MDEA(NI)2005 22	18-Mar-05	Immediate Action	Counterfeit Durex Condoms may have been illegally placed on the UK market (PDF 283 KB)
MDEA(NI)2005 21	11-Mar-05	Immediate Action	Bignell - standard and paediatric Model 2000 single-use Heaf test heads - Bignell Surgical Instruments Ltd is recalling all Heaf test heads currently in circulation (PDF 131 KB)
MDEA(NI)2005 20	03-Mar-05	Action	ELA Medical Alto implantable cardioverter defibrillator (ICD), models 614, 615, 617, 624 and 625 - Premature battery depletion and/or prolonged charge time, leading to loss of cardioversion, defibrillation or pacing therapy. In some cases battery failure has occurred within the recommended three monthly follow-up period (PDF 27 KB)
MDEA(NI)2005 19	03-Mar-05	Action	Ferno Hawk and Ferno Falcon stretcher, incubator and critical care trolleys - Castor wheel bolts have fractured in use, resulting in detachment of the wheel and instability of the trolley (PDF 228 KB)
MDEA(NI)2005 18	24-Feb-05	Immediate Action	Medtronic LIFEPAK 12 external defibrillator/monitor with Adaptiv biphasic technology - The manual default defibrillation energy setting may have become reset to 125 J instead of the energy settings originally set by the user, e.g. 200 J. This could result in the defibrillator not charging to the expected energy level and therefore not delivering appropriate energy to defibrillate the patient successfully (PDF 102 KB)
MDEA(NI)2005 17	23-Feb-05	Immediate Action	Hema Technologies Bilirubin Stat and Bilirubin Plus analysers - Risk of falsely low results (PDF 94 KB)
MDEA(NI)2005 16	25-Feb-05	Action	Old gas fired ovens and other equipment with enclosed burners - Failure of gas to cut off in the event of a flame failure (PDF 94 KB)
MDEA(NI)2005 15	15-Feb-05	Action	Oxoil cefpodoxime combination antibiotic susceptibility discs - Discs may not reliably detect extended-spectrum beta-lactamases (PDF 206 KB)
MDEA(NI)2005 14	09-Feb-05	Immediate Action	Guidant: All lots of VOYAGER RX coronary dilation catheters with 1.5mm to 3.5mm inflated balloon diameters - Risk of air embolism due to possible leakage at the guidewire exit notch situated towards the distal end of the catheter. The manufacturer is recalling all lots of the device (PDF 255 KB)
MDEA(NI)2005 13	09-Feb-05	Action	Pen injection devices and pen needles (PDF 95 KB)
MDEA(NI)2005 12	09-Feb-05	Immediate Action	SOS Ltd and Medical Gas Services Ltd oxygen cylinders, with integral pressure regulators, sold individually and in resuscitation packs by several suppliers - Risk of fire or explosion (PDF 92 KB)
MDEA(NI)2005 11	04-Feb-05	Immediate Action	Becton Dickinson Medical Systems: Central venous catheter kits, arterial catheter kits and percutaneous sheath introducer kits - Risk of infection due to inadequate sealing of the packaging. The manufacturer is recalling certain lots of the above devices (PDF 96 KB)
MDEA(NI)2005 10	24-Jan-05	Information	In-line flexible cable connectors on equipment in wet conditions - Arcing and heat damage (PDF 93 KB)
MDEA(NI)2005 09	19-Jan-05	Action	SP10 Drug Tariff dressing packs - Some batches intended for community use have not been adequately sterilized and may present a risk of infection if used (PDF 95 KB)
MDEA(NI)2005 08	14-Jan-05	Action	Wheelchairs used on vehicle mounted passenger lifts - Incidents resulting in death or serious injury to wheelchair users are occurring as a result of inappropriate use of vehicle mounted passenger lifts (PDF 95 KB)
MDEA(NI)2005 07	12-Jan-05	Action	Owen Mumford UniHeaf AT800 - Heaf testing device - Oven Mumford has ceased production and distribution of this device (PDF 201 KB)
MDEA(NI)2005 06	11-Jan-05	Action	Aventis Optipen Pro insulin pen injection system - Potential for the dosage button to fail to engage at the end of an injection. This could lead patients to believe that the injection has not been successful and to consider performing another injection of insulin (PDF 96 KB)
MDEA(NI)2005 05	10-Jan-05	Action	Bed Rails (Cotsides) - Risk of entrapment and asphyxiation (PDF 96 KB)
MDEA(NI)2005 04	06-Jan-05	Information	Fire Extinguishers - Incorrect maintenance (PDF 105 KB)
MDEA(NI)2005 03	06-Jan-05	Information	Ballast in fluorescent light fittings - Overheating and subsequent fire (PDF 94 KB)
MDEA(NI)2005 02	05-Jan-05	Action	Wheelchairs, seating and accessories - Incidents resulting in death or serious injury to wheelchair users are occurring as a result of failure to adhere to manufacturers' user information or from inappropriate or inadequate maintenance (PDF 99 KB)
MDEA(NI)2005 01	04-Jan-05	Action	Reporting Adverse Incidents and Disseminating Medical Device/Equipment Alerts (MDEAs) (PDF 217 KB)