| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00142-1 |
| Product Name/Description |
Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
Product code: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-53, 0998-UC-0800-53 and 0998-00-0800-83
UDI codes: 10607567109053, 10607567108391 and 10607567108407
ARTG 118266
(Getinge Australia Pty Ltd - Circulatory assist unit, pump, balloon) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/02/2023 |
| Responsible Entity |
|
| Reason/Issue |
Getinge is advising of a product defect correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to four issues that affect IABP performance.
Issue 1: Unexpected shutdown due to failure of the Coiled Cord cable and Cable Assembly backplane to Coiled Cord cable
Issue 2: Unexpected Shutdown due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA.
Issue 3: Leak in the High Pressure Helium Regulator
Issue 4: Helium Leak at the Pump Console Quick Disconnect Fitting
There have been a number of complaints reported for each issue, with zero reported adverse events overall. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Datascope/Getinge are developing hardware/software corrections and updating the Preventive Maintenance instructions to address the above issues. In the interim, users are advised to read and follow the guidance in the customer letter (supplied to impacted facilities by the sponsor).
Issue 1: Inspect the coiled cable cord to ensure there is no visible damage. If unexpected shutdown occurs, attempt to restart and continue with a different IABP.
Issue 2: If unexpected shutdown occurs or a frozen/black screen, attempt to restart and continue with a different IABP.
Issue 3: If this occurs, the internal helium reservoir may be restored by another hospital cart or helium refilling station. If not available, use alternative means of hemodynamic support.
Issue 4: If O-ring is damaged, contact Getinge. If possible remove IABP from patient use until repaired. Use another hospital cart or helium refilling station. If not available, use alternative means of hemodynamic support. |
| Contact Information |
1800 438 464 - Quality.AUNZ@getinge.com – Getinge Australia |