The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2015-00387.Patient information not provided.The other motors referenced were reported under mfr report #2916596-2015-00386 and mfr report #2916596-2015-00388.Device evaluation: the device returned for analysis.The motor, serial number (b)(4) was returned to the manufacturer for evaluation and was found to be defective.The motor intermittently showed infinite impedances at its two motor phases.The review of the device history records for the returned motor revealed that the returned unit was in the field for more than four years.The point of time when the temporary intermittences came into existence could not be determined.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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This is report #2 of 3.Three centrimag motors were received by the manufacturer.No patient identification was provided; however, it was reported that the events involved two separate patients and three motors.One patient was reported to be on bi-ventricular circulatory support, one patient was on single (unspecified) ventricular circulatory support and one of the patients was additionally supported by extracorporeal membrane oxygenation; however, it could not be confirmed which patient.One event occurred while the patient was in the operating room undergoing a mitral valve repair.It was reported that the primary consoles began to alarm with "motor overheat" and "unable to maintain set rpm's" and the pump motors subsequently shut down.The patients were reportedly asymptomatic.The pump motors and primary consoles were exchanged for the back-up devices and the patients continued on support.Attempts were made to obtain further information but to date, no further information was provided.
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