BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problems
Failure to Disconnect (2541); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Event Description
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It was reported that there was a separation between the female connector (dark blue tip) and the main body of the minicap transfer set; further described as ¿the dark blue tip of transfer set started to pull out of the transfer set itself¿.This was observed while disconnecting after peritoneal dialysis (pd) therapy.The patient was unable to disconnect the patient line of the cassette from the transfer set.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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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