Section h4: additional information.Device evaluation: although the reported event could not be duplicated, damage to the motor cable was confirmed via the evaluation of the returned motor.A root cause for the damage could not be determined.Additionally, damage to the motor cable had potential to contribute to the reported event.Upon the console being powered on, an m2 motor connection error was displayed.When trying to proceed and set a pump speed, another m5 error code was displayed.These failures confirmed the findings of the product performance engineering group during prior analysis.The testing found intermittent resistance in the cable when they flexed the cable at the connector end bend relief.The unit was deemed defective and will now be scrapped.Reports of similar events have been documented and corrective action has been initiated to investigate similar issues.Reports of similar events will continue to be tracked and monitored.The centrimag system operating manual states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support".The centrimag motor ifu instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.This document states that if the unit fails to operate according to the motor specifications or a console diagnostic error indicates a centrimag motor malfunction, it should be returned.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.No further information was provided.The manufacturer is closing the file on the event.
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