Section d4: correction.Expiration date not applicable.Manufacturer's investigation conclusion: the reported event of not being able to reach 5500 rpm was not confirmed.The centrimag console (serial#: (b)(6) was returned for analysis and a log file was for review.A review of the downloaded log file showed events spanning approximately 4 days (on (b)(6) 2021 per time stamp).Events occurring on 10aug2021 took place during lab testing at abbott.Throughout the log file, the motor speed was adjusted several times.When the motor speed was adjusted to 5500 rpm, the motor was able to operate at a speed of, around, or slightly above 5500 rpm.There were no other notable alarms active in the log file.The centrimag motor was returned for and the reported event was unable to be confirmed via testing.The console was connected with the returned and associated equipment as well as to test equipment.The console was run for several days at 5500 rpm with no observed issues.The console was able to maintain a speed at 5500 rpm.The console was functionally tested and passed all tests.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 2nd generation primary console (serial#: (b)(6) and the console 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 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.
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