| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00460-1 |
| Product Name/Description |
Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
Distributed from 6 March 2012 to 31 December 2015
ARTG Number: 118266 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Issues have been identified regarding the Video Display Cables, Video Display Assembly (Internal PC Board) and the Pneumatic Assembly for certain Cardiosave Hybrid and Rescue IABPs.
1 - The Cardiosave IABP may have intermittent connectivity issues with the video display cables causing display blanking followed by a “System Failure” audible alarm and shut down.
2 - The Cardiosave IABP Video Display Assembly may shutdown during operation due to a short on the video generator board.
3 - Intermittent connection with the Cardiosave Pneumatic Module Connector resulting in IABP startup failure and/or IABP shutdown.
To date, there has been no reported patient harm or adverse events attributable to these issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is advising users to ensure an alternative device is available at all times as a backup, and that the affected units should not be used during ground or air transport. Maquet will be performing an on-site service to correct the reported issues. This action has been closed-out on 23/01/2017. |
| Contact Information |
1800 605 824 - Maquet |