Section d4: expiration date inadvertently added in initial report and is not applicable for the device.Manufacturer's investigation conclusion: the reported event of b4 alarms was confirmed via the log file; however, the reported event of failed battery maintenance was not confirmed.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 30 days ((b)(6) 2020 per time stamp).¿battery maintenance required: b4¿ alarms were active and muted on (b)(6) 2020 at 06:46:00 and 13:53:00 as well as on (b)(6) 2020 at 06:43:00.A successful battery maintenance was performed on (b)(6) 2020 between 10:05:00 ¿ (b)(6) 2020 at 10:04:00.There were no other b4 alarms following battery maintenance.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was evaluated and tested.The reported event of a b4 alarm was unable to be duplicated.The console never alarmed b4.The console underwent battery maintenance successfully.The console was tested with a test motor and flow probe and always functioned as intended.A full functional checkout was performed, and the unit passed all tests and was returned to the customer site.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 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 has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for 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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