BAXTER HEALTHCARE CORPORATION TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Device Problem
Fitting Problem (2183)
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Patient Problems
Abdominal Pain (1685); Peritonitis (2252)
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Event Date 09/30/2023 |
Event Type
Injury
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Event Description
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It was reported that a peritoneal dialysis (pd) transfer set had a connection issue which resulted in bacterial peritonitis.The connection issue was further described as, ¿thread was not fully covered by transfer set¿.The peritonitis was manifested by abdominal pain and cloudy effluent.It was not reported if the patient was hospitalized for peritonitis.On the same day as the onset, the patient was treated with cephazolin (intraperitoneal, at a dose of four times a day) for peritonitis.At the time of this report, treatment was ongoing, and the patient was recovering from peritonitis.The action taken with pd therapy was unknown.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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The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.The most probable cause of the event is due to a device use issue, as it was reported that the thread was not fully covered by transfer set and patient technique failure.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.Should additional relevant information become available, a supplemental report will be submitted.
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