Manufacturer's investigation conclusion: the reported event of the motor not holding the pump correctly was not confirmed.The centrimag motor (serial#: (b)(6) was returned for analysis to the service depot.The reported event of the motor not holding the pump correctly was not confirmed.A test pump was inserted into the motor several times and was able to operate as intended with no alarms.A full functional test was performed, and the motor passed all testing.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag motor (serial#: (b)(6) and the motor was found to pass all manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 4 entitled "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." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support.The 2nd generation centrimag system operating manual section 7.2.6 entitled "pump set-up" addresses how to properly set the pump up for proper operation.No further information was provided.The manufacturer is closing the file on this event.
|