Medical Device Alerts issued in February 2019

Alerts issued include important actions for enFlow IV fluid and blood warmers due to a risk of unsafe levels of aluminium leaching from the device. Other alerts were issued on implantable cardiac pacemakers, Accu-Chek Insight insulin pumps, and professional use monitor/defibrillator LIFEPAK 15.

In this monthly update, we highlight selected Medical Device Alerts 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.

The following alerts were recently issued:

enFlow IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device (MDA/2019/015). Published 8 March 2019. Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels. An alternative fluid warming device should be used if available. If no alternative is available, a local risk assessment should be done and documented based on a clinical risk-benefit analysis before using this fluid warmer.

Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy (MDA/2019/008). Issued 13 February 2018. Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008).

Accu-Chek Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons. Issued 19 February 2019. Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).

Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy. Issued 20 February 2019. Manufactured by Stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered.

Published 21 March 2019