Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter 의 리콜

Recall

RC-2015-RN-00012-1

Class II

2015-01-09

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00012-1

During manufacturing of the sterile, for patient-use, sensation and sensation plus iabc products, the ferrule cap is intended to be removed from the fiber-optic connection at the time of final packaging.Maquet have identified that during the packaging of some demonstration, fiber-optic sensation and sensation plus iabc units, the ferrule cap was not removed. if the fiber-optic connector on an affected non-sterile, non-patient use, demonstration unit is inserted into patient-use maquet cs300, cardiosave intra-aortic balloon pump (iabp) or iabps upgraded with a fiber-optic module, the cap may become dislodged and remain in the fiber-optic receptacle of the pump.If a pump unit is subsequently used with a clincal use fiber optic balloon catheter inserted into the mating connector, the catheter will notmake an electrical connection with the iabp. the catheter will not be recognised as a fiber optic catheter. the system will still be able to pump as a non fiber optic balloon.

Maquet is providing instructions for the inspection of the demonstration units and the Intra-Aortic Balloon Pumps. End users are requested to inspect and remove the Ferrule caps if present on the pump of demonstration catheter. A Maquet technician will inspect potentially affected devices if required. This action has been closed-out on 11/08/2016.