Manufacturer's investigation conclusion: the reported event of the blood pump not rotating correctly 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 with events spanning approximately 6 days (14jul2022 ¿ 15jul2022, 20jul2022 ¿ 21jul2022, 08aug2022 - 09aug2022 per time stamp).The console was operating a motor at a speed of ~3700 rpm with a flow of ~4.00 lpm.On 15jul2022 at 18:40:38 a ¿flow below minimum: f3¿ alarm activated and at 18:40:40, the motor speed dropped to 0 rpm and the flow became a negative value.At 18:40:43, a ¿set pump speed not reached: m5¿ alarm activated which was followed by a ¿motor alarm: m4¿ at 18:40:53.At 18:41:19, an attempt to set the speed to 3700 rpm was made, but it was unsuccessful.At 18:41:21, a ¿motor stopped: m1¿ alarm activated, and another attempt was made to set to speed and was unsuccessful.The motor was disconnected at 18:42:01 and the unit was powered off at 18:44:15.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis to the service depot.The console was connected to the returned and associated motor (related manufacturer report number 3003306248-2022-12496) 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 duplicated.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 (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 16 entitled ¿console alarms and alerts¿ addresses how to interpret and troubleshoot all system alarms including m5, m4, m1, and f3 alarms.The 2nd generation centrimag system operating manual (rev.L) table 15 entitled ¿console maintenance schedule¿ states that the battery needs to be replaced every 2 years.No further information was provided.The manufacturer is closing the file on this event.
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