No patient involvement.The device returned for analysis(if this is true, if not indicate that the device did not return).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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It was reported that a centrimag motor was connected to a console, the error message "motor disconnected" appeared and the motor would not start.When the problem first occurred, the system was being prepared for use.No patient was involved in this case.The customer sent the motor and pump to the hospital engineers for an investigation.This event was previously not reported due no patient involvement.Abbott made the decision on july 13, 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.
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