Medical device correction for HeartMate III™ Left Ventricular Assist System due to communication error reports between the System Controller and the pump

Transmedic Pte Ltd would like to inform healthcare professionals that errors in communication between the System Controller and pump of the HeartMate III™ Left Ventricular Assist System were reported, at an incidence rate of 1.29%. Abbott have traced this issue to manufacturing variances from a single supplier that could lead to crystallization formation, which may disrupt communication between the pump and the System Controller. This may, in turn, trigger a communication fault advisory alarm on the System Controller. To date, there have been no patient effects related to this issue. Physicians should determine patient care recommendations based on each unique clinical case and remind their patients to contact their VAD Coordinator in the event that an advisory alarm appears on their System Controller. Please refer to the letter for details.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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.