Manufacturer's investigation conclusion: the reported event of the centrimag motor¿s screw being unable to tighten was confirmed.The returned centrimag motor (serial number: (b)(6) was received at the european distribution center, where the motor was observed to have a damaged locking screw upon arrival, and the screw was unable to be turned.The motor¿s locking mechanism was replaced with a new component, resolving the issue.The motor was then functionally tested and was found to perform as intended.Preventive maintenance was performed, and the serviced and repaired motor was returned to the customer site after passing all tests per procedure.The root cause of the reported event 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 emergency / troubleshooting in section 8.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 instructions for use (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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