Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 March 2012 to 31 December 2015 의 리콜

Recall

RC-2016-RN-00460-1

Class I

2016-04-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00460-1

Issues have been identified regarding the video display cables, video display assembly (internal pc board) and the pneumatic assembly for certain cardiosave hybrid and rescue iabps.1 - the cardiosave iabp may have intermittent connectivity issues with the video display cables causing display blanking followed by a “system failure” audible alarm and shut down.2 - the cardiosave iabp video display assembly may shutdown during operation due to a short on the video generator board.3 - intermittent connection with the cardiosave pneumatic module connector resulting in iabp startup failure and/or iabp shutdown.To date, there has been no reported patient harm or adverse events attributable to these issues.

Maquet is advising users to ensure an alternative device is available at all times as a backup, and that the affected units should not be used during ground or air transport. Maquet will be performing an on-site service to correct the reported issues. This action has been closed-out on 23/01/2017.