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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00834-1
Product Name/Description Maquet/Datascope Intra-Aortic Balloon Pump (IABP)

Part Numbers: 0998-UC-0446HXX, 0998-UC-0479HXX

Part Numbers: 0998-00-3013-XX, 0998-UC-3013-XX

Part Numbers: 0998-00-3023-XX, 0998-UC-3023-XX

Distributed between 24 March 2003 through to 11 December 2013

ARTG Number: 118266
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 4/07/2017
Responsible Entity Maquet Australia Pty Ltd
Reason/Issue Getinge has identified a potential issue with the solenoid driver board within the unit of the CS100i, CS100 or CS300 IABP. A complaint was received involving a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure, which has been associated to a patient death due to the failure of the device to initiate therapy.

An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. The lack of power prevents the coil from moving the plunger causing the valve not to open.

These issues could result in an interruption and/or delay in therapy to the patient during use and/or prior to using their CS100i, CS100 or CS300 IABP. A sudden interruption of therapy could result in unsafe, haemodynamic instability. This issue also applies to any System 98 or System 98XT IABP which was converted to a CS100i or CS300 IABP.
Recall Action Recall for Product Correction
Recall Action Instructions Getinge advises:
1. Pursuant to the WARNINGS section of the Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy;
2. Until the service is performed, Getinge recommends powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform;
3. In the event the IABP fails to complete the self-test and exhibits electrical test failure code 58, remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office;
4. In the unlikely event that a sudden interruption of therapy occurs, transfer the patient to an alternative IABP. If an alternative IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. Please refer to the intra-aortic balloon catheter instructions for use; and
5. Each affected facility will be contacted by Maquet/Getinge Service Team to schedule on-site service.

This action has been closed out on the 16/11/2018.
Contact Information 1800 605 824 - Getinge Customer Service