Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00099-1
Product Name/Description	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Model Numbers: 0998-00-0800-XX and 0998-UC-0800-XX (excluding 0998-00-0800-83) ARTG Number: 118266
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	5/02/2015
Responsible Entity	Maquet Australia Pty Ltd
Reason/Issue	Suboptimal thermal management of the power supply may result in the power supply not providing the correct output voltage to the CARDIOSAVE Hybrid IABP console, and the inability to charge the batteries. Failure to provide the correct output voltage to the console will result in the unit not functioning from AC power, even when plugged into an active electrical outlet. Should a power supply malfunction occur, an on screen message will alert the healthcare provider that the CARDIOSAVE Hybrid IABP unit is operating on battery power. The hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy.
Recall Action	Recall for Product Correction
Recall Action Instructions	Users are advised that in the unlikely event that the failure mode was to occur, transfer the patient to an alternative Maquet IABP. If an alternative Maquet IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. Users are advised to refer to the IAB Instructions for Use, Manually Inflating and Deflating a Catheter. The IAB Instructions for Use reiterates that a catheter should not remain inactive for more than 30 minutes, due to the potential for thrombus formation. Alternatively, the IAB could be removed. Maquet anticipates having a replacement power supply available by June 2015. A service representative will contact affected customers to schedule the replacement of the cart power supply. This action has been closed-out on 11/08/2016.
Contact Information	1800 605 824 - Maquet Customer Service