Sarns Centrifugal System, Control Module 의 안전성 경고

Safety alert

2012-11-02

2012-11-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121102.html

Medical device safety alert: terumo sarns centrifugal system, control module medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has initiated a field safety corrective action concerning the control module for sarns centrifugal system, 100/115v. terumo cvs has received multiple reports since 2004 of malfunctions related to components of the sarns centrifugal system, including the centrifugal system for the sarns perfusion system 9000. the reports can be broadly categorized as loss of forward flow, motor noise/vibration, missing/inaccurate flow data, erratic operation, unexpected error messages/alarms, module reset, and smoke seen or smelled. if the centrifugal system is used as the arterial pump, a malfunction could result in loss of arterial flow and a backflow condition. furthermore, if the centrifugal system is used for kinetic-assisted venous drainage, a malfunction could result in inadequate venous drainage. there have been no reports of patient injury as a result of this issue. terumo cvs is notifying users of the reported malfunctions reminding them to review the existing instruction in the operator’s manual, and will provide users an addendum with additional information on reducing patient risk in the event of a malfunction which include a warning to have emergency equipment (manual drive or another pump) and an emergency protocol available, and a recommendation to use a one-way valve. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 2 november 2012.