Manufacturer's investigation conclusion: the centrimag console was evaluated due to the reported event of an m4: motor alarm.However, the centrimag console was not returned for analysis, and no log files were associated with the reported event.The root cause of the reported event was determined to have been an issue with the returned centrimag motor (serial number (b)(6) ) and has been addressed via the motor¿s investigation.The serial number of the centrimag console was not provided.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.No further information was provided.The manufacturer is closing the file on this event.
|