The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2016-00212.Patient information not provided.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 with biventricular extracorporeal circulatory support devices.It was reported that the left ventricle pump motor overheated, causing the console to alarm on (b)(6) 2016 at approximately 10:40 pm.Flow values decreased to 0.47 lpm, the pump speed dropped to 0 rpm, the patient¿s mean arterial pressure decreased to 44 mmhg, and the patient complained of dizziness.The right ventricle pump flows and speed values were unchanged at this time.It was reported that the equipment was well ventilated at the time of the event and was not covered in blankets, pillows, etc.The intensive care unit staff physicians were informed immediately and arrived at the patient¿s bedside.The left ventricle backup console and backup motor were set up and turned on and the devices were switched out.After the switch occurred, it was reported that the flows on the both the right and left pumps became erratic with values down to 1.5-2 lpm and pump speeds between 2000-5000 rpm.The patient was reportedly ambu-bagged and started to have frothy and bloody pulmonary secretions.The patient was started on levophed, vasopressin and epinephrine for support.After a thorough investigation, it was found that the right and left consoles were switched during the equipment exchange (the right pump was at the left pump settings and vice versa).After proper speed adjustments, the flow values returned to 3-6 lpm and the patient became stable.The patient was reportedly alert and able to follow commands, but required vasopressors and additional inotropes for support.The patient was transferred to the cardiothoracic icu for close monitoring and the console and motor were returned for evaluation.No further information was provided.
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