The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning HeartWare Controller, component of a ventricular assist device. The affected product codes are 1400 and 1401AU. All serial numbers are affected.

HeartWare has advised of a recent incident involving a patient death thirty-four months post HeartWare Ventricular Assist System implantation. The patient was found alone and unresponsive with the controller alarming approximately three hours post event.

Log file analysis confirmed that the pump had stopped. Functional testing of the returned controller showed that the device (including motor control circuits) performed all functions as intended within specification and with no fault alarms or errors.

The exact cause of the event cannot be conclusively determined. However, HeartWare suspects that an electrostatic discharge through the exposed controller power ports during battery replacement caused or contributed to data corruption in the pump motor controller resulting in a loss of commutation in which the motor control software was no longer driving the pump's motor controller circuit and leading to a pump stop.

Physicians are reminded of the following:

• Be aware of electrostatic discharge and its potential to cause disruptive and possibly fatal faults to susceptible patients.
• Avoid devices and conditions that may induce strong static discharges (for example, television or computer monitor screens) as electrostatic discharges can damage the electrical parts of the system and cause the left ventricular assist device to perform improperly or stop.
• Always have a backup controller handy and a care giver nearby when changing power sources or controllers. Be watchful for unusual changes in power or flow alarms for a period of time following equipment change.

According to the local supplier, the affected products were not distributed in Hong Kong.

For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00438-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 20 May 2013