Manufacturer's investigation conclusion: the reported event of b1 alarms was not confirmed.The centrimag 2nd generation primary console was not returned for analysis.The root cause for the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.M) 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.M) 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.M) table 16 entitled ¿console alarms & alerts¿ states how to interpret and address all system alarms including b1 battery module fail alarms.¿the console battery will not function.An audible alarm will sound.Switch to the backup console, motor and flow probe according to the procedure described in section 10.1.Resume support.Record the alarm message and contact your abbott medical representative.¿ 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.No further information was provided.The manufacturer is closing the file on this event.
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