Manufacturer's investigation conclusion: the centrimag motor used during the reported event was not returned for analysis and no additional data was submitted.Multiple attempts were made to obtain the product were unsuccessful (both under cs-127051 and cs-125973).As a result, the reported event could not be confirmed during the investigation 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 (doc.#pl-0280 and #pl-0047) 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.No further information was provided.The manufacturer is closing the file on this event.
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