Potential for pump stop events due to HeartWare™ Ventricular Assist Device (HVAD™) System battery electrical fault

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of two battery performance issues related to the HeartWare™ Ventricular Assist Device (HVAD™) System (Model Number 1650DE), that can cause pump stop events if both batteries connected to an HVAD controller malfunction and stop providing power. The issues include a weld non-conformance identified within the batteries that can cause them to fail to deliver power, and an interaction between the battery software configuration and the battery circuit board that can cause electrical faults within the batteries. It is important that patients acknowledge and respond to all battery-related alarms as described in the letter. Healthcare professionals are advised to remind their patients to always keep two sources of power connected to their controller and have fully charged spare batteries available at all times, as well as to follow the other patient management recommendations detailed in the letter. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

12 Jul 2022

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.