advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000 의 안전성 경고

Safety alert

2012-06-22

2012-06-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120622.html

Medical device safety alert: terumo advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000 medical device manufacturer, terumo cardiovascular systems (cvs) corporations, has issued an urgent field safety notice concerning terumo advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ perfusion system 9000. the manufacturer has received multiple reports of false alarms generated by the air bubble detection system used with perfusion system of the above models. it will possibly result in temporary interruption of arterial blood flow, air entrainment in the system, or the need to continue the case with a disabled air sensor. there have been no reports of patient injury as a result of this failure. their investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore, terumo cvs has amended the operator’s manuals for its heart-lung machines to alert all users of the potential for a malfunction of the air bubble detection system and to reinforce the mitigation procedures in the event of a malfunction. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 june 2012.