BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
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 a home patient experienced a connection issue between the female connector of the transfer set and an amia cassette.The event was further described as "could not remove the line from the dark blue connector".This occurred after treatment for peritoneal dialysis therapy.The hp was given antibiotics for preventative care and the transfer set was replaced.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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Correction to d4 and g4.D4: catalogue #: was changed from asku to 5c4482.G4: pma/510k # or bla #: was changed from ni to k152675.H10: the sample was received for evaluation.A visual inspection with the naked eye noted the female connector separated from the main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported separation between the female connector and main body was verified.The cause of the separation between the female connector and main body was due to inadequate solvent application to the set during the manufacturing process.The reported connection issue between the female connector and patient connector of the cassette was not verified.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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