Medical device correction for Thoratec® HeartMate II® LVAS Pocket System Controller due to serious injuries and deaths during backup System Controller exchange by patients

Transmedic Pte. Ltd. would like to inform healthcare professionals of an urgent medical device correction for all HeartMate II^® Pocket System Controller (Model No. 105109) supplied within the following packaging configurations: HeartMate II^® LVAS Implant Kit with Sealed Grafts (Cat. Nos. 106015), HeartMate II^® System Controller (Cat. Nos. 106762). This correction is due to reports of serious injuries and deaths associated with patient’s attempts to exchange the primary System Controller to backup System Controller. A software update that removes non-critical alerts to avoid unnecessary changing of System Controllers and the addition of alignment markings on the System Controller and LVAD’s driveline connector to provide clearer aids during insertion and removal, have been implemented. Healthcare professionals are advised to provide the updated labelling and alarm guides to the patients, remind patients to contact their VAD coordinators in the event that an alarm appears on their System Controllers, and to reinforce that System Controller exchanges are to be performed by their VAD coordinator in the hospital. Please refer to the letter for details.

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.