Manufacturer's investigation conclusion: the reported event of an atypical system stop with a ¿motor failure¿ error was not confirmed.The primary centrimag console was not returned for analysis, and the console in use at the time of the reported event was unable to be determined per additional information.The returned centrimag motor was also found to have performed as intended throughout testing.The root cause of the reported event was unable to be conclusively determined through this analysis.Section 10, entitled "emergency/trouble shooting" of the centrimag primary console operating manual, states: "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.Do not exchange individual motors or individual consoles during patient support." the centrimag primary console operating manual (¿console alarm/alert strategy¿) instructs users on how to resolve alarms that sound from the primary centrimag console and what steps to take in situations where alarms cannot resolve.No further information was provided.The manufacturer is closing the file on this event.
|