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

Transmedic Pte Ltd would like to inform healthcare professionals of the updates in the Instructions for Use (IFU) and Patient Handbook for the Thoratec® HeartMate II Left Ventricular Assist System (LVAS) due to reports of serious patient injuries and deaths associated with the process of changing from a primary Pocket System Controller to a backup Pocket System Controller. Most of these events occurred in patients who were converted to the Pocket System Controller after being originally trained on the EPC System Controller at the time of their HeartMate II LVAS implant. Healthcare professionals are advised to review the updated IFU and Patient Handbook with all personnel responsible for training patients and caregivers on the Pocket System Controller. Healthcare professionals are advised to 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.