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Consumers and health professionals are advised that HeartWare, in consultation with the TGA, has issued a hazard alert for its HeartWare external controller.
The HeartWare external controller is a component of a ventricular assist device, which is used to partially or completely replace the function of a failing heart. The external controller monitors the system and regulates the function of a pump that is attached to the patient's heart.
HeartWare has received reports of loose power or data connectors on the controller.
The external controller is designed to possess a certain level of protection from water exposure. However, if a power or data connector becomes loose, the controller may become vulnerable to water damage, which could cause internal corrosion, electrical faults, reduced speaker volume or connection failures.
If this occurs, potential risks include:
- the pump stopping, which could cause serious injury or death
- loss of communication between the controller and the HeartWare monitor
- reduced ability to detect alarms.
The increased risk of loose power and data connectors has been mostly identified in devices manufactured between October 2014 and May 2015. However, HeartWare recommends that the connectors for all HeartWare external controllers be inspected.
Information for consumers
If you, or someone you provide care for, uses a HeartWare external controller, your device will be inspected at your next regularly-scheduled appointment.
In the meantime, continue to follow all instructions in the patient manual, including guidance on alarm awareness, water avoidance and carefulness when connecting and disconnecting to power and data sources.
If you have any other questions or concerns regarding this issue, contact your treating centre.
Information for all health professionals
HeartWare has written to clinicians who manage the treatment of patients who use a HeartWare external controller providing further information about this issue.
Please be aware of the potential for loose connectors and refer affected patients to their treating centre if they have any questions or concerns.
Information for clinicians
If you are managing the treatment patients who use a HeartWare external controller, advise them of the potential for loose connectors.
Inspect their device for loose power and data connectors at their next regularly-scheduled appointment. Do this by gently pressing on each connector and feeling for atypical movement (do not press hard on the connectors or they could break). If a loose connector is identified, you should replace the external controller with another one from your inventory and contact HeartWare on 02 8935 9400 or email csaustralia@heartware.com.
If the affected external controller is the patient’s primary controller, consider if the risks of exchanging the controller outweigh the risks associated with a loose connector.
Remind your patients to continue to follow all instructions in the patient manual, including guidance on alarm awareness, water avoidance and carefulness when connecting and disconnecting to power sources.
If you have any questions or concerns regarding this issue, contact HeartWare on 02 8935 9400 or email csaustralia@heartware.com.
Reporting problems
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.