| TGA Action ID |
RC-2025-RN-00281-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HeartMate Mobile Power Unit (MPU)
Model number: 107758AU
Serial numbers: 20314704, 20314713, 20314707, 20314711, 20314709, 20314705, 20314710, 20314712
ARTG's 273274, 465645 |
| ARTG Number |
465645 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Abbott has received customer complaints of the Mobile Power Unit (MPU) exhibiting sudden, unexpected performance problems such as not turning on, unprompted shut down, or suddenly turning off and restarting, with the System Controller indicating a Yellow Wrench alarm or “No External Power” alarm.
These problems have been linked to an electrical component in certain MPUs distributed between April 2024 and February 2025. These problems have been linked to an electrical component in certain MPUs distributed between April 2024 and February 2025. At this stage, Abbott is still investigating to confirm the root cause does not affect other devices outside of this date range.
As of February 28, 2025, the complaint rate of MPU performance interruptions within the affected device population is approximately 4%. The reported impacts on patients included anxiety and inconvenience. Although not having been reported, this problem could also potentially lead to serious adverse health consequences such as hemodynamic compromise, thromboembolism, or death when power to the HeartMate left ventricular device is interrupted. |
| Instructions for Customers/Users |
Abbott will replace all affected MPU devices starting June 2025.
Patients:
- If the problems occur, the Backup Battery in the System Controller can power the pump for up to 15 mins.
-Users must switch from the MPU to the fully charged 14V rechargeable batteries within these 15 min. Otherwise, the pump will stop.
- Every time the MPU is used for power, make sure the 14V rechargeable batteries are ready and available for use.
- If the yellow battery sign on the MPU is on, replace the AA batteries inside the MPU immediately. These batteries make the MPU alarms work.
- Do not use this MPU again. Contact your hospital to organise a new MPU.
Physicians/hospitals:
- Send the patient letter to all affected patients.
- Follow the instructions provided in the IFU: If there is an MPU power failure, transfer the patient from the MPU to the 14V rechargeable batteries within 15 mins. The Backup Battery in the System Controller will temporarily power the pump during a power source switch. Do not rely only on the System Controller’s Backup Battery as a power source during power failure, as it will only power the pump for up to 15 mins.
- Do not continue to use the MPU and immediately contact your Abbott Representative for return and replacement.
For impacted MPU units that have not yet been used:
- Do not use these and contact your Abbott Representative to arrange for product return and inventory replacement. |
| Action Commencement Date |
31/03/2025 |
| Responsible Entity |
|
| Contact Information |
0418 497 668 - Nicole Tognetti |