| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00438-1 |
| Product Name/Description |
HeartWare Controller
(Ventricular assist device)
Product code: 1400, 1401AU
All serial numbers are affected
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
HeartWare has advised of a recent incident involving a patient death thirty-four months post HeartWare Ventricular Assist System implantation. 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 (ESD) 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 communication in which the motor control software was no longer driving the pump’s motor controller circuit and leading to a pump stop. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Physicians are advised of the following:
-Be aware of Electrostatic Discharge (ESD) 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 LVAD 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. |
| Contact Information |
02 8078 6164 - Heartware |