Model Number 6379 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/02/2019 |
Event Type
malfunction
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit was displaying that there was still flow and back flow even if the pump was set to zero revolutions per minute (rpm) and the hoses were clamped.No other details regarding the nature of this event were provided.
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Manufacturer Narrative
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The reported complaint was not verifiable.Multiple diligence attempts were unsuccessful for part return so no evaluation could be completed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Manufacturer Narrative
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Updated block: b5.
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Event Description
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Per clinical review:
on (b)(6) 2019, the unit was saying there was flow and backflow when the tubing was clamped and the revolutions per minute (rpms) were set to zero.The problem occurred was marked on bypass, but this cannot occurred during bypass.It is unknown of what the mitigation was, since there was no further information from customer.
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Search Alerts/Recalls
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