NIAIC

Medical Device and Equipment Alerts MDEA Updates - 2012

Number	Issue Date	Level Of Urgency	Title
MDA/2012/027	17 May 2012	Action	Home use blood glucose monitoring system for visually impaired patients. Clever Chek blood glucose monitoring system. Distributed by BBI Healthcare. This meter does not alert users when insufficient blood has been applied. Potential for falsely low blood glucose results if the test strips are under-filled, and falsely high results if over-filled. This could result in inappropriate insulin administration. (PDF 30 KB)
MDA/2012/026	17 May 2012	Action	Dental mouth mirror manufactured by Hager & Werken GmbH & Co. KG Model: Brillant No. 4 Item code: 605400 Lot: MD-4/31Due to a manufacturing defect the mirror may become detached from the frame. This may present a choking hazard for patients. (PDF 46 KB)
MDA/2012/025	09 May 2012	Action	Point of care diagnostic test for monitoring anticoagulation therapy.i-STAT PT/INR cartridges. Lots beginning with R11 or R12. Manufactured by Abbott Point of Care. There is a potential for INR results from the affected device to be falsely elevated by approximately 20%. This may lead to inadequate anticoagulation and potential thromboembolic complications (PDF 32 KB)
MDA/2012/024	09 May 2012	Action	Endoscope accessory holder. All manufacturers. Use of inappropriate accessory holders within automated endoscope reprocessors (AER) may lead to contamination of devices, equipment and processing media by retained soil and corroded material from the endoscope accessory holder.(PDF 36 KB)
MDA/2012/023	08 May 2012	Action	Alaris® IVAC® 590 series blood set. Product reference G59980. NHS Supply Chain code: FSB537. Manufactured by CareFusion. Specific lot numbers. The manufacturer has received reports of leakage between the sleeve tubing and the drip chamber joint of the blood set. This could lead to a delay in treatment and increase the risk of infection. The manufacturer issued a Field Safety Notice (FSN) in March 2012 but has not had sufficient confirmation from users that they have received and acted on this information. (PDF 27 KB)
MDA/2012/022	25 April 2012	Action	Dermal filler for breast augmentation.Macrolane™ Volume Restoration Factor (VRF). Manufactured by Q-Med AB (a Galderma division). Use of MacrolaneVRF20 and Macrolane VRF30 for breast augmentation can make diagnosis of breast cancer more difficult, particularly with the use of mammography. (PDF 14 KB)
MDA/2012/021	24 April 2012	Action	Left ventricular cardiac resynchronization therapy (CRT) leads. Bipolar QuickSite and QuickFlex lead models: 1056T, 1058T, 1156T and 1158T.Manufactured by St Jude Medical. Risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation. (PDF 40 KB)
MDA/2012/020	13 April 2012	Action	This alert supersedes MDA/2008/18 Oral swabs with a foam head. All manufacturers. Foam heads of oral swabs may detach from the stick during use. This may present a choking hazard for patients. (PDF 21 KB)
MDA/2012/019	11 April 2012	Action	Air- or gas-pressurised spray devices for application of sprayable fibrin sealants used for intra-operative haemostasis. Risk of life-threatening or fatal embolism. The MHRA is aware of incidents of fatal air or gas embolism occurring during, or immediately after, application of fibrin sealants using air- or gas-pressurised spray devices. These adverse events appear to be related to the use of spray devices to apply fibrin sealants when either the pressure setting is greater than recommended or when the device is held closer to the tissue surface than is recommended by the manufacturer. (PDF 19 KB)
MDA/2012/018	04 April 2012	Action	AlboGraft polyester vascular graft. Manufactured by LeMaitre. All lots. Prohibition Notice issued Potential for blood leakage (or other adverse incident) with these grafts. The reported leaks have occurred at implantation. (PDF 57 KB)
MDA/2012/017	04 April 2012	Action	Disposable syringes and tubing used with contrast media injectors during imaging procedures, manufactured by Covidien. Sterility may be compromised as the packaging of these devices may not be sealed. The MHRA is not confident that the recall of these devices has been effective or that users have received and acted upon the information provided in the manufacturer’s Field Safety Notice (FSN).(PDF 21 KB)
MDA/2012/016	02 April 2012	Action	Metal-on-metal (MoM) total hip replacements:MITCH TRH acetabular cups/MITCH TRH modular heads (Finsbury Orthopaedics) when implanted with uncemented Accolade femoral stems (Stryker Orthopaedics). Increased rates of revision of metal-on-metal total hip replacements when MITCH TRH acetabular cups/MITCH TRH modular heads are used in combination with uncemented Accolade femoral stems.(PDF 21 KB)
EFA/2012/002	29 Mar 2012	Action	Equipment using ultraviolet (UV) tubes. Ultraviolet light tubes (UVA, UVB and UVC) are interchangeable and the wrong type can be fitted to equipment. Risks include radiation burns and loss of effectiveness.(PDF 36 KB)
MDA/2012/015	29Mar 2012	Action	Sterile indigo carmin - used as a chromoendoscopy dye during endoscopy. Manufactured by Derm Tech. Supplied in the UK by Diagmed. All product manufactured sterile. In September 2011, the manufacturer identified that indigo carmin dye manufactured sterile may change to an unexpected colour and/or exhibit a weak colour. The manufacturer issued a Field Safety Notice to inform users of this issue. The MHRA has been informed that the recall of affected product has been completed. However, the colour variation and/or weakness could have made the dye less effective in highlighting mucosal abnormalities. (PDF 32 KB)
MDA/2012/014	16 Mar 2012	Action	Implantable cardioverter defibrillators (ICD). EnTrust VR/DR/AT. Models: D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, and D154VRC. Manufactured by Medtronic. Risk of loss of ICD/pacing therapy after elective replacement indicator (ERI) is reached, due to rapid battery depletion occurring approximately 2½ years after implantation. (PDF 26 KB)
MDA/2012/013	15 Mar 2012	Action	Electrosurgery instrument. LigaSure Dolphin Tip sealer/divider LS1500 and LS1520 manufactured by Covidien. Specific lot numbers. The handle pins may disengage, possibly compromising the removal of tissue from between the jaws. In an open procedure there is an additional risk that the disengaged handle pin may fall into the patient cavity and remain unnoticed.(PDF 55 KB)
MDA/2012/012	15 Mar 2012	Action	Patient vital signs monitor. IntelliVue models MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, D80, MX600, MX700, MX800.Manufactured by Philips Healthcare.Affected software revision H up to and including H.15.36. Patient vital signs monitors may not visually or audibly alarm to alert users at the central station. Should this occur, those monitoring the central station may not be alerted to a patient’s condition requiring intervention.(PDF 15 KB)
MDA/2012/011	5 Mar 2012	Action	Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All implanted devices. In March 2010 the MHRA was informed by the French regulatory authorities (AFSSAPS) that most PIP silicone gel breast implants manufactured from January 2001 were filled with an unapproved silicone gel material. The MHRA’s advice for the management of women implanted with PIP silicone gel breast implants after 1 January 2001 was given in MDA/2010/078, published in October 2010. (PDF 22 KB) The recommendations in this MDA update the advice given in MDA/2010/025 and MDA/2010/078.
MDA/2012/010	07 Mar 2012	Action	AlboGraft Polyester Vascular Graft: manufactured by LeMaitre. All Lots. Potential for profuse bleeding (or other adverse incident) with these grafts (PDF 44KB)
MDA/2012/009	01 Mar 2012	Action	Level 1® Normothermic IV fluid administration sets, specific lots of model numbers D-60 HL and DI-60HL. Hotline® Blood and IV fluid warming sets, specific lots of model numbers L-70, L-70NI, L-80, L-270, and L-370. Manufactured by Smiths Medical. Smiths Medical has become aware of an increase in the number of reports of disconnections of the Luer lock connector at the patient end of the tubing for these fluid warming sets. This can lead to a risk of fluid/ blood loss or delay in therapy. The MHRA cannot be confident that these recalls have been effective and that users have received and acted on the information provided in the manufacturer’s Field Safety Notices (FSNs). (PDF 20 KB)
MDA/2012/008	28 Feb 2012	Action	All metal-on-metal (MoM) hip replacements. The MHRA is issuing updated information and advice about the management and monitoring of patients implanted with metal-on-metal (MoM) hip replacements. (19 KB) The recommendations in this Medical Device Alert (MDA) replace the advice previously given in MDA/2010/033 and MDA/2010/069
MDA/2012/007	23 Feb 12	Action	Aquarius haemofiltration machine using softwareversion 6.01. Supplied and supported by Baxter Healthcare Ltd. Manufactured by Nikkiso Europe (previously Edwards Lifesciences Ltd).The revised software upgrade version 6.02.06,replacing software version 6.01, has beenpostponed pending further validation by themanufacturer. (PDF 36 KB) This alert replaces MDA/2011/095 (issued in September 2011).
MDA/2012/006	20 Feb 2012	Action	Histology laboratory reagents: Primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15). Labelled NovocastraTM and BondTM both manufactured by Leica Biosystems. Primary antibody to CD2 (clone 11F11) has been labelled as CD7 (clone LP15). Conversely, primary antibody to CD7 (clone LP15) has been labelled as CD2 (clone 11F11). Antibody expression may vary between T-cell proliferations and T-cell lymphoma. There is a risk of misclassification of lymphoma tumours and subsequent delay to diagnosis or delayed or inappropriate treatment. (PDF 24 KB)
MDA/2012/005	16 Feb 2012	Action	Stapler Duet TRSTM universal straight and articulating single use loading units (SULU) Manufactured by Covidien.Covidien has issued advice following reports of serious injuries that have occurred following the use of these devices in the thoracic cavity.These stapler loading units have the potential to injure adjacent anatomical structures within the thorax, which may result in life threatening postoperative complications. (PDF 21 KB)
MDA/2012/004	09 Feb 2012	Action	Reagents requiring manual handling for use in combination with cobas c501/502analyser made by Hitachi. Multiple tests are affected, such as syphilis (TPLA) test made by Sekisui. All supplied by Roche. The use of insufficient volumes of reagent may lead to a false negative result leading to patient harm such as: a missed diagnosis of syphilis; a delayed diagnosis of organ rejection; a delayed diagnosis of the end of remission for malignant lymphoma patients. It is possible to obtain ‘valid’ but inaccurate results when there is no reagent remaining in the Roche cassette.(PDF 62 KB)
MDA/2012/003	1 Feb 2012	Action	Catheter valve manufactured by Coloplast. Item number: 380851 Specific lot numbers. Coloplast is recalling this product due to a sterility issue associated with the catheter valve. These devices are normally supplied sterile. The manufacturer issued a Field Safety Notice (FSN) for this device on 10/11/2011, but has not had sufficient confirmation from users that they have received and acted on this information. A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website.(PDF 26 KB)
MDA/2012/002	19 Jan 2012	Action	Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend. Manufactured by Smiths Medical. Lot numbers from 1631477 to 1923406 inclusive. Incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect. This may cause the tube to dislodge, requiring it to be changed. The manufacturer has initiated a recall of affected tubes. The manufacturer issued a Field Safety Notice (FSN) – dated 15 November 2011 (see appendix 2) – but has not had confirmation from all users that they have received and acted on this information. (PDF 21 KB)
EFA/2012/001	19 Jan 2012	Action	Integral side-stay mechanism window restrictors fitted with plastic spacers and used in many window applications. Certain types of side-stay window restrictors incorporate a plastic spacer which, if allowed to deteriorate and crack, may result in separation of the retaining rivet and failure of the restrictor. Even with a restrictor fitted to each side of the window, the failure of one restrictor may be enough to allow egress with high risk of injury or death. (PDF 94 KB)
MDA/2012/001	17 Jan 2012	Action	Rusch Flexislip/Flexi-Slip™ endotracheal tube stylet with soft distal tip, 6F. Manufactured by Teleflex. Product codes: 502501 size 6Fr and 503700 size Ch 6. Specific lots affected. Teleflex is undertaking a recall following complaints received about two problems: difficulty removing the stylet from the endotracheal tube after intubation, separation of the PVC sheath from the stylet Either problem may result in injury and the need for medical intervention. Teleflex issued a Field Safety Notice (FSN) on 22 November 2011 but has not had sufficient confirmation from users that they have received and acted on this information. (PDF 25KB)