Manufacturer's investigation conclusion: the reported event of the centrimag motor being unable to be recognized by the centrimag console was confirmed.The returned centrimag motor (serial number (b)(6) ) was received at the european distribution center.The motor was connected to a known working test centrimag console, and the motor was not recognized by the console, as an m2: motor disconnected alarm and an s3: system fault alarm were both observed.The motor¿s cable was measured, and fluctuations in the motor cable¿s continuity were observed when the motor was manipulated approximately 10 inches from its motor-end bend relief.Two wires in the motor¿s cable correlating to one of its drive phases were also observed to be damaged through these measurements.The motor was scrapped as a result of these findings.The root cause of the observed wire fatigue within the motor¿s cable was unable to be conclusively determined through this analysis.Review of the device history record for centrimag motor, serial number (b)(6) , showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 9.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.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.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.Additionally, this document instructs the user to always have a spare centrimag motor and back-up equipment available.No further information was provided.The manufacturer is closing the file on this event.
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