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 08/05/2023 |
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 and the main body of the minicap transfer set; further described as ¿tiny piece of blue fell off transfer set¿.This occurred during use of the device of peritoneal dialysis therapy.The patient was unable to disconnect from the cassette and had to cut the patient line to disconnect from the cycler.The transfer set was replaced.There was no report of patient injury or medical intervention associated with this event, however the patient was given prophylactic treatment.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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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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