Medical Device Alerts issued in January 2020
Alerts were issued about Convex two-piece skin barriers for use with ostomy bags and HeartStart XL+ defibrillators. A notice was also issued following reports of falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology of the ADVIA assay.
In this monthly update, we highlight selected Medical Device Alerts and notices that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.
Alerts
Convex two-piece skin barriers (Natura /Surfit/Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002). Issued 16 January 2020. Manufactured by ConvaTec – specific batches of convex two-piece skin barriers have been incorrectly manufactured with off-centre starter/stoma hole. The alert advises to share this information with all those who may also have affected product, including patients, to identify and arrange for return of affected devices.
Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy (MDA/2020/003). Issued 28 January 2020. Manufactured by Philips – due to hardware or software issues the device may fail to start, unexpectedly restart or deliver defibrillation therapy at the wrong energy level. The alert advises following the recommended actions of two recent Field Safety Notices and, if possible, have ready access to a backup defibrillator until the corrective actions have been undertaken.
Notice regarding patients using phenindione
Healthcare professionals may also wish to be aware of a recent notice from Siemens Healthcare following reports of falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology of the ADVIA assay. The instructions for use (IFU) for the ADVIA Chemistry ECRE_2 assay will be updated to indicate that use of this assay is not recommended for patients undergoing treatment with phenindione, due to the potential for falsely depressed results.