Health Canada — Medical Devices · Canada · 2013-01-07 · Type II
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Reported risk: Terumo Cardiovascular Systems (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 follows: Loss of forward flow, motor noise/vibration, missing/inaccurate flow data, erratic operation, unexpected error messages/alarms, module reset, and smoke that was seen or smelled.
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