Section a: patient information was requested but was not provided.Manufacturer's investigation conclusion: the reported event of the console not functioning as intended and the flow dropping to 0 lpm around the event date was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 3 days ((b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2021 per time stamp).On (b)(6) 2021 at 18:29, ¿flow below minimum: f3¿ and ¿set pump speed not reached: m5¿ alarms activated.The motor speed fell to ~0 rpm with a flow of ~0 lpm.These alarms were able to be muted and cleared.The motor speed and flow recovered at 18:30:10.This sequence of events occurred again at 18:46:16, 18:55:10, and 19:41:50.Each time, the pump speed and flow were able to recover.On (b)(6) 2021, at 09:26, ¿flow below minimum: f3¿ and ¿pump not inserted: m3¿ alarms activated.The motor speed and flow fell to 0 rpm and 0 lpm respectively.A ¿motor disconnected: m2¿ alarm activated at 09:29:09.Following this alarm, the motor speed remained at 0 rpm; however, the flow recovered and remained stable until the console was powered off at 14:32:22.There were no other notable events active in the log file.The 2nd generation primary console was returned for analysis to the service depot.The reported event was unable to be reproduced during testing.The console was opened for inspection and was visually inspected.No anomalies were found.The console was then connected to test equipment and a test loop for several days.No alarms were active during testing.A full functional test was performed, and the unit passed all tests.Good faith efforts were sent to retrieve additional information including the exact event date; however, no response was received.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 qa specifications.The console was originally shipped with backup battery (serial #: (b)(6)).The 2nd generation centrimag system operating manual (rev.L) 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 (rev.L) 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 (rev.L) table 13 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including m2, m3, m5, f2, and f3 alarms.No further information was provided.The manufacturer is closing the file on this event.
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