Manufacturer's investigation conclusion: the centrimag console (serial number (b)(4)) was not returned for analysis.No log files associated with the reported event were provided.All atypical events were addressed via the centrimag motor¿s investigation (serial number (b)(4), evaluated under mfr #2916596-2019-05508).As the console was not returned, the root cause of the reported event was unable to be determined through this analysis.The labeling has an emergency/troubleshooting section for the primary console.The recommended practice, whenever there is a console or motor malfunction, is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console to continue patient support.No further information was provided.The manufacturer is closing the file on this event.
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