Sarns 8000 manual1/5/2023 ![]() ![]() there were no known reports of patient injury as a result of these issues. ![]() 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. ![]() The malfunctions can be broadly categorized as loss of wall (ac) power, battery back-up malfunction and battery status indicator malfunction. 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. 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. Medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs) has initiated a field safety corrective action concerning sarns modular perfusion system 8000. Medical device safety alert: terumo sarns modular perfusion system 8000
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