Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP) 의 리콜

Recall

RC-2017-RN-00093-1

Class II

2017-01-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00093-1

Maquet has identified an issue with the li-ion battery used with the cardiosave iabp. if the li-ion battery is accidentally dropped, the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions, battery venting has the potential to create smoke, a foul odour, and sparks. there has been no reported patient harm or adverse events attributable to this issue. there have been 3 reported occurrences of the battery venting when dropped to date.

A Maquet Representative will schedule an on-site visit to affix a “Do Not Drop” label on the battery and provide additional instructions which will indicate to take extra care to avoid dropping the battery. Additionally, Maquet is in the process of providing a re-usable transport and storage case which will allow for the transport and storage of spare batteries. Future shipments of CARDIOSAVE Li-Ion batteries from Maquet will be shipped in the re-usable transport and storage container. Users are advised not to take spare batteries for transport applications, until they are provided with the re-usable transport and storage case.