Manufacturer's investigation conclusion: the reported event of the centrimag console¿s line fuses being open was confirmed.The returned centrimag console (serial number l04503-0001) was received at the service depot and was unable to be powered on due to its damaged line fuses.After troubleshooting, the console¿s 24-volt power supply was determined to be the cause of the damaged line fuses.The 24-volt power supply and damaged line fuses were replaced with new components, then the console was able to power on as intended.The console was functionally tested alongside known working test centrimag equipment and was found to perform as intended after its repair.A full functional checkout was performed, and the serviced and repaired console was returned to the customer site after passing all tests per procedure.A log file was also extracted from the console and was reviewed.The console was not observed to have been in patient use within the timeframe of the reported event (jun2021).The console was observed to have been powered on twice on the date of the reported event, 28jun2021.The console alarmed with a b6: on battery alarm, indicating that the console was unable to properly operate on ac power which may indicate an issue with the console¿s power supply, this observation being consistent with the console¿s functional testing.No other notable events were observed.The console¿s original 24-volt power supply was forwarded to the ppe department for further analysis.The power supply¿s components were electrically measured, and one of its fuses was observed to have been open.A damaged fuse on the 24-volt power supply could have caused the console¿s line fuses to become damaged; however, the root cause of the damage to the fuse on the power supply was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag console, serial number l04503-0001, showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.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.The 2nd generation centrimag system operating manual instructs users on how to exchange the centrimag console¿s line fuses.No further information was provided.The manufacturer is closing the file on this event.
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