Manufacturer's investigation conclusion: the centrimag motor used at the time of the reported event was not returned for analysis.Additionally, no motor related issues were reported.A request for product return was made and the customer responded that the alarm cleared and never happened again.The customer was made aware that they needed to perform battery maintenance.They also reported that no items will be returned to abbott.As a result, the reported event could not be confirmed and the root cause of the issue could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual in section titled "battery maintenance procedure", outlines the battery maintenance procedure and indicates that the battery maintenance procedure should be performed every 6 months.This section also warns that if the system displays the message battery charger fail or battery module fail after battery maintenance is performed, then do not use the system.The 2nd generation centrimag system operating manual section 9.4-"battery maintenance procedure" outlines the battery maintenance procedure and indicates that the battery maintenance procedure should be performed every 6 months.This section also warns that if the system displays the message battery charger fail or battery module fail after battery maintenance is performed, then do not use the system.The 2nd generation centrimag system operating manual section 4-"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-"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-"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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