BAXTER HEALTHCARE CORPORATION CAPD DISCONNECT Y SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number L5C4366 |
Device Problems
Disconnection (1171); Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2020 |
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 two (2) units of ultra set capd disposable disconnect y-sets had issues when the nurse was connecting the y-set to a patient's peritoneal dialysis (pd) transfer set.This was further described as the y-set "did not attach to the transfer set and it slipped off." this occurred twice on the same patient while preparing for the start of a peritoneal dialysis therapy session.The transfer set remained in use.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 devices were discarded; 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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