Manufacturer's investigation conclusion: the reported event of the centrimag motor atypically stopping while in use was not confirmed.The returned centrimag motor (serial number: (b)(6) was received at the service depot.The motor was functionally tested alongside known working test centrimag equipment and was found to operate the mock loop as intended.Atypical events were unable to be reproduced throughout all testing, even when the entirety of the motor¿s cable was manipulated by hand.The serviced and tested motor was returned to the customer site after passing all tests per procedure.No log files were associated with the reported event, and 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 quality assurance specifications.The 2nd generation centrimag system operating manual (rev.11) section 3 "about the 2nd generation centrimag primary console" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." centrimag motor ifu (rev.06) 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.
|