Sarns Modular Perfusion System 8000 의 안전성 경고

Safety alert

2012-11-02

2012-11-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121102a.html

Medical device safety alert: terumo sarns modular perfusion system 8000 medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs) has initiated a field safety corrective action concerning sarns modular perfusion system 8000. terumo cvs has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the sarns modular perfusion system 8000. very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. the malfunctions can be broadly categorized as loss of wall (ac) power, battery back-up malfunction and battery status indicator malfunction. terumo cvs’ initial investigation found that the operator's manual for the sarns system 8000 does not provide sufficient instruction on how to respond to a flashing red indicator light and how to ensure the function of the battery back-up prior to each case. there were no known reports of patient injury as a result of these issues. the manufacturer is informing sarns system 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user with additional instructions. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 2 november 2012.