HeartWare Ventricular Assist System
Hazard alert due to multiple potential safety issues.
Consumers and health professionals are advised that HeartWare, in consultation with the TGA, has issued a hazard alert for its HeartWare Ventricular Assist System to provide information about multiple potential safety issues.
HeartWare Ventricular Assist System is a ventricular assist device, which is used to partially or completely replace the function of a failing 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.
As a result of ongoing performance monitoring for this device, HeartWare has identified five potential issues.
HeartWare has produced a 'Patient Communication' to provide further information to users and minimise risks of adverse events. The 'Patient Communication' has been sent to cardiologists who are managing the treatment of patients with a HeartWare Ventricular Assist System, with instructions to provide it to the users.
- Worn alignment guides
It has been identified that the alignment guides in the device controller's power supply connector ports may wear down over time, which may allow the connectors to move while the metallic connection pins are still engaged. If this happens, the connection pins can become damaged. This can potentially lead to battery discharges or pump stops, which can cause serious injury or death.
- Failure of internal 'Double Disconnect Alarm' battery
The device's controller has an internal battery that powers an alarm in the unlikely event that both power sources are simultaneously disconnected. Like all batteries, this battery can fail with age. If both power sources are simultaneously disconnected and the internal battery is dead or underpowered, there may be no audible alarm.
- Loss of communication between controller and batteries
It has been identified that a temporary loss of communication between the device controller and the batteries can sometimes contribute to premature 'battery switching' or false battery alarms. In most of these cases, power is not lost to the controller and there is no loss of functionality for the device.
- Driveline outer sheath discolouration and cracking
It has been identified that the driveline outer sheath may become discoloured or crack over time. This outer, protective covering contains a plastic material that can degrade if exposed to excessive ultraviolet light, including direct sunlight and lights used in tanning beds. While the device will continue to work correctly if the driveline outer sheath becomes discoloured or cracked, there is an increased risk of the patient experiencing infections at the driveline exit site.
- Snagging or pulling of the driveline
Patients are reminded to take care when managing their driveline to avoid accidental snagging or pulling, which could result in damage or disconnection from the device controller. If this happens, it can cause electrical issues or pump stops, which could lead to serious injury or death.
HeartWare is currently developing solutions to address these issues.
Information for consumers
HeartWare has written to cardiologists who manage the treatment of patients with a HeartWare Ventricular Assist System providing further information about the above issues, including a 'Patient Communication' to be provided to users.
If you or someone you care for has a HeartWare Ventricular Assist System and you have not been contacted or received the 'Patient Communication', you should contact your cardiologist. Alternatively, you can phone HeartWare on 02 8078 6164 or email csaustralia@heartware.com.
The 'Patient Communication' provides the following recommendations for HeartWare Ventricular Assist System users:
- Worn alignment guides
You should take care when connecting to power sources. Inspect your device controller's power supply ports for signs of wear or damage to the alignment guides or connector pins. If damage is found, be careful when connecting to power sources so as not to twist or bend the connector pins and contact your cardiologist. It may be necessary to arrange for a replacement controller.
- Failure of internal 'Double Disconnect Alarm' battery
You are reminded to follow the Patient Manual. In particular, you should never disconnect from both power sources at the same time. It is also advised that you make sure that someone else is with you when changing power sources.
- Loss of communication between controller and batteries
You should treat all battery alarms in the ways described in the Patient Manual.
- Driveline outer sheath discolouration and cracking
You are advised to keep the driveline outer sheath protected from excessive ultraviolet light, including direct sunlight and lights used in tanning beds. Keep your driveline protected under your clothing while in direct and indirect sunlight. However, be careful not to limit access to the device controller connection in a way that could interfere with a controller exchange if one becomes necessary.
- Snagging or pulling of the driveline
Take care when managing your driveline to avoid snagging or pulling on things like door knobs, seatbelts or brake handles. Do not pull, kink or twist your driveline. If the driveline becomes damaged, do not try to repair it yourself, as this could lead to injuries. You should contact your cardiologist so they can determine if repair by a HeartWare technician is necessary.
If you have any questions or concerns about this issue, contact your cardiologist.
Information for all health professionals
HeartWare has written to cardiologists who manage the treatment of patients with a HeartWare Ventricular Assist System providing further information about the above issues, including a 'Patient Communication' to be provided to users.
Be aware of the above issues. Refer affected patients to their cardiologist if they have any questions or concerns.
Information for cardiologists
HeartWare has written to cardiologists who manage the treatment of patients with a HeartWare Ventricular Assist System providing further information about the above issues, including a 'Patient Communication' to be provided to users.
If you are managing the treatment of a patient with a HeartWare Ventricular Assist System, you are advised to familiarise yourself with the information provided in the 'Patient Communication'.
Provide the 'Patient Communication' to affected patients and advise them about these issues accordingly.
If you have any questions or concerns about this issue, phone HeartWare on 02 8078 6164 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.