Section a: confirmation of patient involvement was requested but not provided.Manufacture¿s investigation conclusion: the reported event of loss of pump speed and flow was able to be confirmed via review of the log file; however, was unable to be reproduced during product testing.The centrimag motor (serial number: (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 6 days ((b)(6) 2022 per timestamp).Events captured on (b)(6) 2022 took place in the testing labs at abbott.The console was operating a motor at a speed of ~4000 rpm and a flow of ~3.4 lpm.On (b)(6)2022 at 04:17:00, a system alert: s3¿ alarm was activated and the pump speed fell to 3000 rpm causing a ¿pump speed not reached: m5¿ alarm to activate.The alarm was followed by a ¿motor alarm: m4¿ triggered by sub-fault ¿sf_lmc_levitation¿.The pump speed was changed multiple times on (b)(6)2022 from 04:17:00 ¿ 04:24:00.The motor was disconnected and the system was shut down on (b)(6)2022 at 04:24:00.The motor was connected and the system was shut down periodically from (b)(6) 2022 at 10:41:00 ¿ (b)(6)2022 at 10:00:00.The pump speeds were intermittently adjusted throughout this duration as well.A can bus send error and system alert: s3 alarms were active on (b)(6) 2022 at 10:51:00.The system was shut down on (b)(6)2022 at 10:00:00.There were no other notable alarms active in the log file.The centrimag motor (serial number: (b)(6)) was returned for analysis to the service depot.The console and motor was connected to the returned and associated motor and a mock loop for several days.During operation there were no alarms observed and it operated as intended.The reported event was unable to be reproduced.Multiple good faith effort attempts were made asking if the cause of the loss of flow/pump speed was identified, if the alarms were resolved, if any troubleshooting was performed, and if product will be returning; however, no response was received.The root cause of the reported event was unable to be conclusively determined through this investigation.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 table 13 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot system alarms including m4 and s3 alarms.The device history records were reviewed for the centrimag motor (serial number: (b)(6)) and the motor was found to pass all manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.
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