| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00117-1 |
| Product Name/Description |
CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0
ARTG Number: 179104 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Maquet Cardiopulmonary has received several complaints from the field reporting that after startup with either AC or DC power, the CARDIOHELP System generated the pop-up window "Battery X Needs Service" or "Both Batteries Need Service" (X refers to the number of built-in battery, e.g.
Battery 1). The alarm messages did not occur during device operation (including the switch from AC to DC power and vice versa) .
Maquet Cardiopulmonary's internal investigations have identified that there is a likely occurrence of the above mentioned error messages due to software bugs in the communication between the controller module and operating system . However, it is not possible for the user to distinguish the genuine alarm messages caused by batteries from the incorrect alarm messages caused by the software bugs. Maquet Cardiopulmonary received no reports of any adverse patient outcomes as a result of this error message. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The new software version (version 3.4.6.0) corrects software bugs that resulted in the generation of incorrect "Battery Needs Service" error messages. This software revision and the method for upgrading affected systems will be provided via the normal Service Letter process. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 605 824 - Maquet Australia |