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 Type
malfunction
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Event Description
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It was reported that two (2) minicap transfer sets were unable to disconnect from the bag safely.This was observed during use of the devices for peritoneal dialysis (pd) therapy, while disconnecting.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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B3/d10 (event date): the event occurred on an unspecified date in march 2024, reported as "this week." should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information was added to h3, h6, and h10: h10: the actual devices were not available; however, two (2) photographs of the samples were provided for evaluation.A review of the photos did not show visual evidence of the reported problem.The reported condition was not verified.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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