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 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 there was a separation between the female connector (navy blue) and the main body of the minicap transfer set; further described as ¿the navy blue part separated from the rest of the set." this was observed while disconnecting after peritoneal dialysis (pd) 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 to resolve the issue.There was no report of patient injury or medical intervention associated with this event, however the patient was treated with prophylactic antibiotics.No additional information is available.
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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 not received for evaluation; 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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