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Health Sciences Authority
Dear Healthcare Professional Letters

Risk from incorrect insertion of HeartMate 3™ modular cable into the controller by patients during controller exchange

Audiences

Healthcare professional

Product type

Medical devices

24 December 2019

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Abbott Medical (Singapore) Pte Ltd would like to inform healthcare professionals of reports of the HeartMate 3™ modular cable being incorrectly inserted into the controller by patients during controller exchange. Incorrect connection, as a result of patient exchanges outside of the hospital setting, may result in serious injury or death. Healthcare professionals are advised to reinforce to HeartMate 3™ patients the instructions to system controller exchange during their next clinic visit. These include a review of the HeartMate 3™ Patient Handbook, ensuring that the patient understands the need for having a caregiver present and all labelling instructions followed during System Controller exchange away from the hospital, and training patients on the process for exchanging controllers. 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.

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