Manufacturer's investigation conclusion: the reported event of the centrimag system fully stopping was not confirmed.The returned centrimag battery (serial number (b)(6) was individually tested and was found to perform as intended.However, due to the battery¿s expiry date, the battery was scrapped.Although an issue was not observed within the centrimag battery, issues that may have contributed to the reported event were identified via the centrimag console¿s and centrimag motor¿s investigations.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag battery, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.Section 10, entitled "emergency/trouble shooting" of the centrimag primary console operating manual, states: "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 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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