BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4483 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2022 |
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 there was a connection issue between the titanium adapter and the patient adapter of the peritoneal dialysis (pd) transfer set.The connection issue was further described as, ¿unable to connect tightly¿.This was observed during use of the device for pd therapy.There was no report of 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: the sample was received for evaluation with a cap attached to the female connector.A visual inspection was performed with the naked eye and no issues were observed.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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