Medical Device and Equipment Alerts (MDEA) Updates - 2008

Issue Date             
Level Of Urgency
18 Dec 08
Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637. Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning
Previously published in NI as MDEA(NI)2008/91
28 Oct 08
Storm3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare.The original tie-down brackets fitted to these wheelchairs are not suitable for the new heavy duty four point webbing tie-down systems manufactured by Unwin Safety Systems Limited
Previously published in NI as MDEA(NI)2008/080
03 Oct 08
The risk to water supplies, in sensitive hospital areas, from microbiological water treatment / Failure to remove chemicals, (Silver-stabilised hydrogen peroxide and similar based chemicals), used for microbiological treatment of water supplies can produce a risk of exposure to potentially dangerous chemicals, which can cause severe injury to patients
23 Sept 08
Implantable cardioverter defibrillators – all manufacturers and models / Risk of electric shock to clinicians or mortuary personnel while removing implantable cardioverter defibrillators (ICDs), Risk of explosion during ICD incineration, Need to maintain device/data integrity for ICDs subject to investigation
Previously published in NI as MDEA(NI)2008/71
19 Sept 08
Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix). Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect
Previously published in NI as MDEA(NI)2008/069
11 Sept 08
Neurostimulator programmers manufactured by Medtronic – N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders. An error in the programmer software (revision NNB_01) may lead to false warnings of a low battery status. There is a risk that pre-existing symptoms may return if the device ceases to function when true low or end of service battery warnings are subsequently ignored
Previously published in NI as MDEA(NI)2008/068
21 Jul 08
Puma and Beatle battery powered wheelchairs manufactured by or Handicare. Some variants of the Puma and Beatle are too heavy for standard four point webbing tie-down systems for use in a vehicle
Previously published in NI as MDEA(NI)2008/056
03 Jul 08
Lancing devices (used in pharmacy settings) – all brands / Risk of transmission of blood borne infections between patients if a lancing device is used for multiple patient testing, contrary to the manufacturer's instructions for use
Previously published in NI as MDEA(NI)2008/050
9 June 08
All manufacturers / Implantable drug pumps for intrathecal therapy / Risk of temporary or permanent neurological impairment due to inflammatory or granulomatous mass formation at the catheter tip
Previously published in NI as MDEA(NI)2008/042
9 June 08
All posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs / Use of an inappropriate type of, or incorrectly fitted or adjusted posture/safety belt can lead to death or serious injury of the occupant
Previously published in NI as MDEA(NI)2008/041
30 May 08
Duvet covers and other soft furnishings / risk of self harm
23 May 08
Lotus Professional compact toilet roll holder/dispenser: risk of ligature source
23 May 08
Patient weigh scales. Potential for medication errors due to incorrectly calibrated or type of weigh scales, giving inaccurate readings or inappropriate scales being used
18 Mar 08
Needle free intravascular connectors. all brands: There is a risk of infection if the top/septum of the connector remains recessed within its housing. Swabbing of the connector in this condition may lead to inadequate decontamination
Previously published in NI as MDEA(NI)2008/017
10 Mar 08
Medical air plant: risks associated with critical component failure.
Two incidents have been reported involving failure of 4-bar medical air plant due to a fault in the central control unit (CCU) printed circuit board (PCB) and motor control unit (MCU) PCB with fuses. This resulted in the loss of all three medical air compressors for over 24 hours, requiring the hospital to use the emergency reserve manifold (ERM) and secure sufficient replacement medical air cylinders to meet demand
13 Feb 08
Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers: A bolus of air was forced up the venous line to the heart when a quick-prime line was misconnected to the vent port of a hard-shell venous reservoir.A problem with a vaporiser prevented the oxygen supply reaching the oxygenator
Previously published in NI as MDEA(NI)2008/005
17 Jan 08
Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd - Total knee replacement implants -VKS, RT- Plus and TC- Plus femoral and tibial knee components / Extension of recall of implants which may have incorrect alloy composition
Previously published in NI as MDEA(NI)2008-003

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