Manufacturer's investigation conclusion: the reported event of a damaged set screw was confirmed.The centrimag motor (serial #: (b)(6)) was returned for analysis and was evaluated and tested.The reported event was visually verified; the locking screw was damaged and unable to rotate.The locking ring was replaced with a new one.The motor was functionally tested and operated as intended.The motor passed all tests and was returned to the customer.The replaced locking ring was forwarded to product performance engineering (ppe) for analysis and the locking ring damage was confirmed.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 qa specifications.The 2nd generation centrimag system operating manual, rev.11, section 4, entitled "warnings & precautions" warns that "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, rev.11, 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." no further information was provided.The manufacturer is closing the file on this event.
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