| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00001-1 |
| Product Name/Description |
HeartWare Controller
(Ventricular assist device)
Product Codes:1400, 1401XX
Range of Serial Numbers: CON000001 through CON005472
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
In 2013, HeartWare advised clinicians (TGA Reference: RC-2013-RN-00438-1) on measures to take in relation to patient safety risks associated with electrostatic discharge (ESD) following two incidents of patient deaths where the electrostatic discharge (ESD) was suspected to cause or contribute to data corruption in the pump motor Controller resulting in a loss of commutation.The risk of injury associated with ESD includes the interruption of circulatory support due to a pump stop. Since the 2013 Field Safety Corrective Action, HeartWare have received reports of one additional death and one additional serious injury in which ESD may have caused or contributed to data corruption in older Controllers resulting in the loss of commutation to pump motors, which ultimately led to pump stops. The affected Controllers exhibit a higher susceptibility to ESD than newer Controllers.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Clinicians are requested to inspect inventory and quarantine all affected controllers. For patients who possess affected Controllers (both primary and backup) Clinicians are advised as follows:
(a). For Primary Controllers: Review the applicable risks and if medically advisable, exchange the affected Controller under medical supervision with a new Controller (serial number CON005473 or higher).
(b). For Backup Controllers: Contact the patient and arrange to have the backup Controller replaced with a new Controller (serial number CON005473 or higher).
A HeartWare representative will contact the clinicians to assist with this process and to help replace affected Controllers where necessary. This action has been closed-out on 14/07/2016. |
| Contact Information |
02 8078 6164 - HeatWare Pty Ltd |