Catalog Number 5C5479 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the supply line of an amia set disconnected from the cassette, leading to a leak of solution.This occurred during peritoneal dialysis (pd) therapy.The patient was connected at the time of the event.The registered nurse (rn) stated that the supply line broke off from the cassette where the tubing was fused to the main cassette piece.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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