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 06/02/2022 |
Event Type
malfunction
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Event Description
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It was reported that the female connector of a minicap transfer set could not be disconnected from a solution bag.This occurred after use of the device for peritoneal dialysis (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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Initial reporter address: (b)(6).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 with a minicap attached to the female connector.A visual inspection with the naked eye noted a separation between female connector and main body.Functional testing including leak, clear passage, and clamp function testing was performed with no issues noted.The reported condition was verified.The cause of the condition was determined to be manufacturing related.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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