Manufacturer's investigation conclusion: the reported event of the centrimag console not properly received ac power was confirmed.The returned centrimag console (serial number (b)(6) was received at the european distribution center.The console was unable to be properly powered on when connected to ac power and operated on battery power when plugged into ac power.The console was troubleshot, and the console¿s 24-volt power supply was found to have been electrically damaged.Due to the console being a v1 unit, the unit was unable to be repaired and was scrapped as a result of the damage to the power supply.The console¿s damaged power supply was to be sent to the ppe department for further analysis; however, the part was misplaced at the service depot.Further troubleshooting was unable to be performed as a result.The root cause of the damage to the console¿s power supply was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 3 entitled "about the 2nd generation centrimag primary console" 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 8 entitled "emergency / 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." no further information was provided.The manufacturer is closing the file on this event.
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