BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4483 |
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 09/02/2023 |
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 minicap transfer set had a connection issue; further described as ¿the dark blue portion would just spin instead of disconnecting from the patient line." this was identified while disconnecting from peritoneal dialysis therapy.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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H10: the device was received for evaluation with a patient connector attached to the female connector of the transfer set.A visual inspection with the naked eye identified a separation between the female connector and the main body of the twist clamp.Functional testing including leak, clear passage and clamp function testing were performed with no issues noted.The patient connector was connected and disconnected by hand with no issue noted.The reported condition of connection issue was not verified, however, the condition of separation between the female connector and the main body was verified.The cause of the separation was determined to be manufacturing related due to inadequate solvent to the insert chip.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported 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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