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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It was reported that a centrimag pump had pump stoppages.The console displayed "motor disconnected" alarm.When manipulating the cable, the alarm would sound.Not patient was involved with this issue.This event was previously not reported due to 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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