The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2017-00738.This report is being submitted as additional information.The device returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.
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The patient was supported by an extracorporeal circulatory support device (ecmo).A system fault alarm occurred, and the pump speed reportedly dropped to zero.It was reported that the unit ¿stopped working¿, and the speed read --- the flow read 0.0 lpm, and the read out below said ¿system failure¿.The cannulas, lines, power cords, and pump placement were checked.The console was power cycled, and device operation continued.The patient had no blood flow and decreased blood pressure for 2-3 minutes.The unit worked properly after restarting.The hospital clinicians were unable to wake the patient, and the patient had decreased neurological response.The patient was off sedation for approximately 24 hours.The console continued to operate the device as expected; however, during the transfer of the patient to the transport stretcher, it was reported that the exact same system failure happened with all the steps repeated above.During this second episode, the console would not restart, and continued to read ¿system failure¿.The console was exchanged to a backup console.It was reported that the exchange took 3-4 minutes, with no blood flow and decreased blood pressure.The hospital clinicians were unable to wake the patient, and the patient had decreased neurological response.The patient was off sedation for approximately 24 hours.No further additional was provided.
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