BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; 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 05/09/2022 |
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 female connector of a peritoneal dialysis (pd) transfer set and the patient line of a homchoice cassette.The customer was unable to disconnect the transfer set from the patient line of the cassette.This was observed during an unspecified process step of peritoneal dialysis therapy.To resolve this issue, 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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Additional information was added to h6 and h10.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The device 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 at the female connector was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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