PRA number
2016/15229
Published date
Product description
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.
Reasons the product is recalled
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 hazards to consumers
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.
What consumers should do
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.
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.
Supplier
Heartware Pty Ltd
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.