| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00991-1 |
| Product Name/Description |
Maquet/Datascope Intra-Aortic Balloon Pump (IABP)
Product Numbers: CS100i IABP, CS100 IABP, CS300 IABP
Part Numbers: 0998-UC-0446HXX, 0998-UC-0479HXX, 0998-00-3013-XX, 0998-UC-3013-XX, 0998-00-3023-XX, 0998-UC-3023-XX
ARTG Number: 118266 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Maquet/Getinge has received complaints involving the CS100/CS100i and CS300 IABPs regarding the following issues:
1. False blood detection alarm; and
2. The ingress of fluids into the IABP affecting various electronic circuit boards.
No serious injuries to patients have been reported as of August 2017. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Each affected facility will be contacted by a representative of the Getinge Service Team to schedule on-site service of the CS100/CS100i or CS300 IABP.
This action has been closed out on the 26/11/2018. |
| Contact Information |
1800 438 464 - Getinge Customer Service |