Section h4: additional information.Section g9: the initial report was sent with an incorrect first mfr number (2916596).The correct number is 3003306248.Manufacturer's investigation conclusion: review of the device history record for centrimag motor s/n l06641-0023 showed the device was manufactured in accordance with manufacturing and qa specifications.The reported event of the centrimag motor¿s centrifugal pump screw being damaged was confirmed.The returned centrimag motor (serial number (b)(6)) was observed to have a bent locking screw upon arrival.The motor was functionally tested by the ppe department and was found to perform as intended throughout all testing despite the observed damage.The damaged locking mechanism was replaced with a new component, and the serviced motor was returned to the customer site after passing all tests per procedure.The root cause of the damage to the motor¿s locking mechanism was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 10.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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