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HeartWare Ventricular Assist Device AC adapters and batteries
Hazard alert - potential for loss of power
Consumers and health professionals are advised that HeartWare, in consultation with the TGA, has issued a hazard alert for its HeartWare Ventricular Assist Device (HVAD) due to issues with certain lots of AC adapters and batteries. HeartWare is also recalling the affected components and replacing them.
The HVAD system takes over some or all of the pumping function of the heart. The device includes a pump which is attached to the patient's heart and is connected via a driveline to an external controller that regulates the pump's function and monitors the system. The system is implanted either in patients awaiting heart transplants or as an alternative to transplantation.
HeartWare has identified separate issues affecting certain lots of its AC adapters (power supplies connected to a wall socket) and batteries. Some of HeartWare's AC adapters are vulnerable to power grid surges above 220 volts and, when affected, will automatically switch to a back-up power source (batteries). In addition, some HeartWare batteries supplied before December 2014 have the potential to lose their charge prematurely.
The serial numbers to check are highlighted with red dotted
ovals on the AC adapter, above left, and battery, above right.
The yellow dotted ovals highlight the stickers to be placed
on the devices after they are recalled.
In either case there is the potential for additional risk to the patient from not being connected to back-up power sources and this could lead to serious injury or death if the remaining power source is insufficient or fails.
The serial numbers of affected devices are:
- HeartWare AC adapters with serial numbers within the range CAC000001 to CAC005796
- HeartWare batteries with serial numbers within the range BAT000001 to BAT199999.
Information for consumers
If you or someone you care for has an implanted HeartWare device check the serial numbers on your AC adapter(s) and batteries. If the serial numbers are within the ranges listed above you should contact your cardiologist or the hospital where the operation was performed to arrange for replacement. If you are unsure of the serial numbers on your AC adapter(s) and batteries, please contact your cardiologist.
If an AC adapter fails, the patient's controller will sound an alarm and automatically switch to an alternative power source. The patient or carer should follow HeartWare’s Instructions for Use (IFU) and patient manual and replace the failed AC adapter with a backup AC adapter (or another power source).
If batteries drop their charge prematurely an escalating alarm will sound, notifying the patient/carer of a critical battery condition. In such an event, the patient/carer will need to immediately connect an additional power source to the controller to avoid a pump stop. Patients are advised to always have available two fully charged spare batteries and a spare AC adapter.
All AC adapters and batteries with serial numbers in the ranges listed above should be replaced.
If you have any questions or concerns regarding this issue, please contact your cardiologist.
Information for all health professionals
If you are treating a patient who has a HeartWare implant, advise them of this issue. Assist the patient to identify if they have an AC adaptor and/or battery within the ranges of serial numbers listed above.
If your patient does not have any components listed within the serial number ranges, reassure them that their devices are not affected by this recall notice.
If the patient does have a device affected by this recall, refer them to the cardiologist and/or hospital where the procedure was performed for a replacement.
If they have any further questions or concerns about the above issue, refer them to their cardiologist.
Information for cardiologists and hospitals
HeartWare has written to cardiologists who have implanted the HeartWare HVAD system and HeartWare clinicians advising them of these issues and the recall procedure.
HeartWare advises clinicians to arrange for affected patients to bring their AC adapters and batteries to an appointment as soon as possible (within three months at most), for the components to be replaced.
If you have further questions or concerns regarding these issues, contact HeartWare on firstname.lastname@example.org.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.