| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00265-1 |
| Product Name/Description |
CARDIOSAVE Hybrid and Rescue Intra-aortic Balloon Pumps (IABP)
(Used to inflate and deflate intra-aortic balloons for temporary support of the left ventricle via the principle of counter-pulsation)
Part Numbers: 0998-00-0800-XX and 0998-UC-0800-XX
Distributed between 6 March 2012 to 20 October 2015
ARTG Number: 118266 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Maquet has received reports that, in some CARDIOSAVE IABPs, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. When the scroll compressor fails, one of two high priority alarms will appear on the IABP display and patient therapy could be interrupted. The high priority alarms are “Autofill Failure” and “IAB Catheter Restriction”. If either of the high priority alarms cannot be resolved, the event may be attributable to the scroll compressor failure and therapy to the patient cannot be manually restarted.
In this situation and where supported by the IABP to stabilise their haemodynamic status, patients present with critical conditions (particularly those in transit), there is a risk for severe and possible irreversible injury.There are no complaints reported associated with a patient injury or death. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is providing work around instructions for users to follow as an interim measure. A software upgrade will be installed as a permanent correction. An updated operator’s manual is being provided which includes additional important information regarding the configuration, alarms in the presence of ESI and self-checks for the compressor. Users are advised the units can continue to be used while the software is being implemented, however it is recommended that if available, they use an alternative unaffected device based on the individual benefit-risk assessment and particularly for patients in transit. If users choose to use an affected CARDIOSAVE IABP it is recommended that an alternative device is available for back-up. |
| Contact Information |
1800 605 824 - Maquet |