The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Medtronic HeartWare Ventricular Assist Device (HVAD) System Battery Charger AC Adapter and Controller [Model Number: 1610AU, 1640AU; All Serial Numbers].
The manufacturer advises of the potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. When this occurs, communication circuits between the battery and the Controller may be damaged. If circuit damage occurs, it will be necessary to exchange the Controller to restore communication between the batteries and Controller. Power to the Controller and to the HVAD Pump will continue to be maintained if a Battery Charger AC Adapter is mistakenly inserted into a Controller power port and a secondary power source also is connected to the Controller.
The manufacturer will be providing an addition to the clinician HVAD Instructions For Use (IFU) and Patient Manual. Through 13 January 2020, there have been 36 complaints reported to the manufacturer potentially related to this issue. From this population, there has been one reported death resulting from complications associated with a related Controller exchange.
The manufacturer is advising clinicians to instruct patients to carefully follow the guidance provided in the updated patient manual related to connecting a power source. Patients are advised to pay attention when connecting and disconnecting power supply cables to ensure the correct cable is being connected to their Controller. The manufacturer will provide a copy of the updated IFU and Patient Manual to all affected users once it is approved for release.
For details, please refer to the following link:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2020-RN-00102-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 February 2020