Manufacturer's investigation conclusion: the reported event of the flow reading showing as a dotted line was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(4)) was not returned for analysis.Additional provided information communicated on 21mar2022 stated that this did not involve a patient and the hospital does not want to send any equipment back.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)(4)) 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 section 5.1.5.1 entitled ¿front panel¿ states ¿a disconnected or malfunctioning probe will display dashes.¿ no further information was provided.The manufacturer is closing the file on this event.
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