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Health Sciences Authority
Dear Healthcare Professional Letters

Potential for a HVAD™ System user to mistakenly insert the Battery Charger AC Adapter into a HVAD Controller power port

Audiences

Healthcare professional

Industry member

Product type

Medical devices

12 February 2020

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 (HCPs) of a potential for a HeartWare® Ventricular Assist Device (HVAD) System user to mistakenly insert the Battery Charger AC Adapter into a HVAD Controller power port. This may cause damage to communication circuits within the Controller, resulting in the Controller no longer displaying LED indicators related to battery status. Additionally, alarms will also occur when any battery is connected to the Controller.  The Controller will continue to receive power from any power source that remains successfully connected, including a secondary battery. If circuits within the Controller are damaged as the result of this issue, it will be necessary to exchange the Controller, which could lead to patient harm due to pump stoppage. HCPs are reminded to instruct patients to carefully follow the patient manual regarding power source connection and to report any persistent, unexpected audible tones to their clinician for additional instructions. 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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