The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery manufactured by HeartWare Inc. The affected products are identified as follows:
According to the alert, HeartWare AC Adapters with the above serial numbers are vulnerable to power grid surges above 220 volts.
If an AC Adapter fails, the patient's Controller will alarm and automatically switch to the other power source. If patients follow the manufacturer's Patient Manual, there are no elevated risks to health. However, if a patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a failed AC Adapter, the system could lose power, which may lead to serious injury or death.
There have been complaints related to earlier than expected battery depletion for batteries with serial numbers BAT000001 to BAT199999. Premature or unrecognised battery depletion may pose a risk to the patient, if the patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a depleted battery.
The manufacturer is advising healthcare professionals to identify and quarantine the affected units in hospital inventory and arrange for current patients to bring their AC Adapters and Batteries to a clinic as soon as possible (at least within the next three months), with urgency dependent upon individual patient circumstances.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-01261-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 December 2015