Medical Device and Equipment Alerts MDEA Updates - 2010

Number
Issue Date                        
Level Of Urgency
Title
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.
EFA/2010/012
13 Dec 2010
Action
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.
EFA/2010/011
24 Nov 2010
Action
EFA/2010/010
19 Oct 2010
Action
EFA/2010/009
19 Oct 2010
Immediate
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
Please note further advice is given in MDA/2012/011
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.
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.
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.
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.
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.
EFA/2010/008
27 July 2010
Action
EFA/2010/007
8 July 10
Action
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.
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.
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).
EFA/2010/006
09 June 2010
Action
NIA/2010/001
02 June 2010
Action
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.
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.
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.
EFA/2010/005
08 April 2010
Action
EFA/2010/004
07 April 2010
Immediate Action
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.
Please note further advice is given in MDA/2012/011
EFA/2010/003
29 Mar 2010
Action
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.
EFA/2010/002
16 Mar 2010
Action
EFA/2010/001a
16 Mar 2010
Action
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.
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.
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
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)
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
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
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
EFA/2009/002
30 Dec 2009
Action
Hexagon

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