03 Oct 2018

CLH Blog - MHRA Field Safety Updates For September

CLH Blog - MHRA Field Safety Updates For September

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Beckman Coulter - Lipase OSR6x30 Uric Acid OSR6x98 HDL-Cholesterol OSR6x87 Enzymatic Creatinine OSR6x204 - Urgent Field Safety Notice

ISSUE: NAPQI (N-acetyl p benzoquinone imine), a metabolite of Paracetamol, causes negative interference with Enzymatic Creatinine OSR6x204, HDL Cholesterol OSR6x87, Lipase OSR6x30 and Uric Acid OSR6x98 assays, at levels present in the serum/plasma of overdose patients. IMPACT: NAPQI in toxic concentrations may potentially lead to erroneously low results for Enzymatic Creatinine, HDL Cholesterol, Lipase and Uric Acid. The risk to patient safety of this event has been determined as remote for Enzymatic Creatinine and highly unlikely for the remaining assays. Paracetamol itself does not interfere with the assays.

ACTION: No action is required by your laboratory. However, laboratories should be aware that there is a remote probability that NAPQI in toxic concentrations may potentially lead to erroneously low results for Lipase, Uric Acid, HDL-Cholesterol and Enzymatic Creatinine.

RESOLUTION: The following statement will be added to the Interfering Substances section of the Lipase, Uric Acid, HDL-Cholesterol and Enzymatic Creatinine IFUs (BLOSR6x30, BLOSR6x98, BLOSR6x87 and BLOSR6x204, respectively): “N-acetyl-p-benzoquinone imine (metabolite of paracetamol) will generate erroneously low results in samples for patients that have taken toxic doses of paracetamol.”

FSN date: 3rd September 2018

Zeiss - Carl Zeiss Meditec AG 611P CT Lucia Intraocular Lenses | +11.5 D - Urgent Field Safety Recall

Carl Zeiss Meditec is initiating this action due to detection of a potential labelling error that resulted in a total of Nine (9) units that were possibly mislabeled with the wrong dioptric power. This may lead to myopic or hyperopic post-operative refractive outcome and potential explanation of the lens. Continued use of the serial number listed below is not recommended.

FSN date: 4th September 2018

Abbott - CentriMag™ Acute Circulatory Support System Motor Model: 201-10002 Compatible with CentriMag™ Pump and PediVas™ Pump - Field Safety Notice

This communication is to remind our physician and hospital partners of the importance of following the proper method for exchanging the CentriMag System in the event your system experiences an interruption of power.

Specifically, to: • Reinforce availability of a full backup system including a console, motor, flow probe, and power cable • Ensure proper care and handling of the Centrimag Motor cable • Provide guidance on inspection of motor cable for damage Our analysis of devices associated with the motor stop field complaints showed that the motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection. This damage may be avoided by ensuring proper handling, such as avoiding tight bending of the cable or winding the cable around the motor during storage during the life of the motor.

CentriMag System Risks and Identified Corrections: To date, Abbott is aware of two (2) instances of patient death and six (6) additional instances of serious injury related to the damaged motor cable. These events were the result of the lack of a backup system or an improper exchange when switching to a secondary back-up motor and console when a motor cable failure occurred. The CentriMag System includes audio and visual alarms, and the Instructions for Use require that a full backup system be in the vicinity of any patient on support. Both the backup system and the alarms help ensure that even if cable damage were to occur, resulting in interruption of support, that switching the backup system will safely resume support.

FSN date: 5th September 2018

Abbott - Accelerator APS - Urgent Field Safety Update (Action Required)

Abbott has identified an issue in the modules listed below. The transport mechanism that moves the robot along the axes generates a magnetic field which may interfere with pacemaker/implanted heart defibrillator functionality at close distances. This affects all APS system serial numbers. The table below lists modules that contain this transport mechanism.

Abbott has identified that the required pacemaker/implanted heart defibrillator safety label shown below was not applied to the module covers to warn laboratory technicians who have a pacemaker/implanted heart defibrillator about the risk in case they operate these modules.

FSN date: 7th September 2018

Boston Scientific - LATITUDE™ Programmer model 3300 - Urgent Field Safety Notice

Boston Scientific is retrieving all units of LATITUDE™ Programmers Model 3300 in the field, due to the potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation. The LATITUDE™ programmer model 3300 is designed to communicate with and program Boston Scientific pacemakers and defibrillators noninvasively.

The PSA software application on the LATITUDE™ Programmer model 3300 can be used to assess the electrical performance and placement of cardiac lead systems during implant of the device. Boston Scientific has received reports of unintended cross-chamber stimulation of the right ventricle (RV) while pacing the right atrium (RA) using the PSA software.

The most common clinical outcome is a slightly prolonged procedure to allow for evaluation of the observation. While there is a theoretical potential for life threatening harm due to induced tachyarrhythmia, Boston Scientific has received no reports of patient injury associated with this observation. This behavior is limited to the PSA software application on the LATITUDE™ programmer model 3300. The table below shows the affected product identification.

Part Number GTIN Model Country / Region 623300-100 00802526585005 3300 US 623300-200 00802526597206 3300 Europe Actions 1. Segregate all affected product to ensure that it will not be used. 2. Your Boston Scientific sales representative will retrieve any Model 3300 LATITUDE Programmers at your facility.

FSN date: September 2018

We’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us @CLHGroup to let us know and don’t forget to use '#CommittedToCare' in your posts.

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