| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00281-1 |
| Product Name/Description |
CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)
Serial Number: All devices up to 90410628 excluding S/N 90410622 and 90410626
ARTG Number: 179014 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
1 - There have been reported cases of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touchscreen) of the CARDIOHELP device. All manual settings are lost and the system will revert back to the original clinical settings.
2 - Through internal testing, it has been determined that there is a possibility that electromagnetic interference due to electric current fluctuations may cause pressure valves on the display to "freeze". |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is providing work around instructions to prevent risk of injury to the patient in the unlikely event of the failure mode occurring during use. Maquet has updated its current CARDIOHELP-i software to version 3.3.2.0 and this will be installed by an authorised Maquet service technician. |
| Contact Information |
1300 304 372 - Maquet Australia |