Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2023-04656.The mfr number should have been fei-based with the 10-digit fei being (b)(4).Patient information was requested but was not provided.Manufacturer's investigation conclusion: the reported event of flow alarms not activating was not confirmed.Review of the submitted photos revealed that when the flow reading dropped below the threshold a flow alarm would activate, as expected.The centrimag console was not returned for analysis.Multiple attempts were made to obtain additional information, including if any products will be returned for analysis, and if any log files were available for review; however, no response was received.The root cause of the reported event could not be conclusively determined through this analysis.The serial number of the centrimag console was not reported with the event.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 section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including flow related alarms, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.
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