Approximate age of device 6 months 6 days.The device returned for analysis.The complaint investigation determined the reported event was the result of a software design related 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.Manufacturer's investigation conclusion: the reported event could not be confirmed nor reproduced during testing of the returned centrimag motor (serial number (b)(4)).The motor was evaluated and tested by tech service.The reported complaint could not be duplicated during the investigation.The motor was tested for an extended period of time with its related centrimag 2nd gen console.The motor was operated at different speeds and flow rates without any flow issues or atypical alarms being reproduced.The motor's cable was inspected and no issues were observed.The motor was then functionally tested per the centrimag motor service process and the unit passed all tests.The returned motor was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined nor correlated to the returned motor.The tested motor was returned to the customer site.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.
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The patient was being supported by an extra corporeal circulatory support pump or acute biventricular extra corporeal circulatory support.It was reported that during animal trials in atlanta there was an issue with centrimag hardware.A console's screen went blank; the motor continued to run, however the user had to swap the console and motor onto a backup.The console and motor were both returned for evaluation.No additional information was reported.This event was previously not reported because there were no allegations of cmag motor issues identified.Abbott made the decision on (b)(6) 2019 to initiate a voluntary recall, therefore, this event is being upgraded to reportable.
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