Urgent Medical Device Correction for Thoratec® HeartMate II® LVAS Pocket System Controller

Transmedic Pte Ltd would like to notify healthcare professionals on the importance of monitoring the expiration date of the 11V Lithium-Ion Backup Battery (“backup battery”) in the Thoratec® HeartMate II LVAS System Controller. This is due to a recent trend in reports of serious injuries and deaths associated with patients attempting to exchange System Controllers in response to Advisory alarms triggered when backup battery is not replaced by the first day of the month of the battery’s expiration date. Healthcare professionals are advised to review the new information for the Monthly Safety Checklist in the revised Instruction for Use and assess the hospital’s processes and procedures for ensuring the replacement of backup batteries for patients’ primary and backup System Controllers prior to the month of expiration. 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.