| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00365-1 |
| Product Name/Description |
Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)
ARTG Number: 118266 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
The fan assembly for specific System 98/98XT, CS100/CS100i and CS300 IABPs could potentially contain a misshapen retaining ring. This retaining ring could disengage within the fan assembly, causing the fan to stop rotating, which causes the power supply to overheat and the IABP to shut down without any visual or audible warning. Patients receiving IABP therapy are in critical condition and a sudden interruption of therapy could result in unsafe haemodynamic instability. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Clinicians are instructed to not leave the patient unattended during IABP therapy. Maquet is reminding users of the current warning in the IABP operating instructions ie, the patient balloon should not remain inactive in the patient (i.e., no inflating or deflating) for more than 30 minutes, due to the potential for thrombus formation. In the unlikely event that this situation was to occur, transfer the patient to an alternative Datascope IABP. If an alternative Datascope IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate.
A Maquet Service Representative will contact hospitals to schedule the replacement of the fan assembly. |
| Contact Information |
1300 304 372 Maquet Australia Pty Ltd |