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Health Sciences Authority
Dear Healthcare Professional Letters

Potential damage to Medtronic HVAD™ Controller Ports due to repeated misalignment during insertion of Power Cables, Alarm Adapter and Monitor Data Cables

Audiences

Healthcare professional

Industry member

Product type

Medical devices

16 March 2021

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

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of the potential for the Heartware™ Ventricular Assist System (HVAD™) Controller ports to be damaged due to repeated misalignment during insertion of the Controller power cables (AC Adapter, DC Adapter, and Battery cables), Alarm Adapter, and Monitor data cables, causing wear on the power/data cables or damage/bending of the Controller port metal pins. This damage can result in the inability to fully lock the cable connectors into the Controller, potentially causing power interruptions or disconnections to the Controller and subsequent controller power loss and HVAD™ Pump stop or loss of communication with the HVAD™ Monitor. Medtronic had received 855 (2.96%) complaints related to this issue. Medtronic is in the process of redesigning the HVAD™ Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD™ Alarm Adapter, and HVAD™ Monitor data cables using a new internal connector plug material intended to reduce the risk of damage caused by this issue. Healthcare professionals are advised to review the additional patient management instructions provided in the letter. These include the recommendations to inspect the HVAD™ Controller, HVAD™ Controller power cables (AC Adapter, DC Adapter, and Battery cables), and HVAD™ Monitor data cables with their patients during clinic visits, to replace damaged or worn AC adapters, DC Adapters, Batteries and Alarm Adapters with new components and to reinforce information in the existing Instructions for Use and Patient Manual regarding Controller Care, Battery Care and cable connections. 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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