Manufacturer's investigation conclusion: the reported event of the backup centrimag system atypically stopping was confirmed; however, the centrimag console was determined to have been unrelated to the cause of the event.A log file was extracted from the returned centrimag console during testing (serial number: (b)(6).The log file contained data from on (b)(6) 2022 at 13:12 to on (b)(6) 2022 at 13:48 per timestamp.The system was observed to be operating around ~3000 rpm / 1.2 lpm throughout the data until on (b)(6) 2022 at 10:00 when the system was manually shut down.The system was not observed to have been in patient use after this time.Atypical events and alarms, including m5 and s3 alarms, were not observed throughout the data.The returned backup centrimag console was tested alongside the returned backup centrimag motor (serial number: (b)(6), evaluated separately).The reported system stop was reproduced upon manipulating the motor¿s cable.The returned motor was also tested alongside a known working test console, and the reported event was further reproduced, narrowing down the cause of the event to the backup centrimag motor.The returned console was functionally tested alongside known working test equipment and was found to perform as intended.As a result, the motor was scrapped, and the console was returned to the customer site after passing all tests per procedure.Review of the device history record for centrimag 2nd gen.Primary console, serial number: (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 "warnings & precautions" 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." no further information was provided.The manufacturer is closing the file on this event.
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