BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Abdominal Pain (1685); Peritonitis (2252)
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Event Date 01/07/2024 |
Event Type
Injury
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Manufacturer Narrative
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This report is for a breach in aseptic technique which resulted in peritonitis. 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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Event Description
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A peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis.The breach in aseptic technique was not further described.The peritonitis was manifested by cloudy pd fluid and abdominal pain.Two days after the event onset, the patient was hospitalized and treated with vancomycin injection (1gm, every 5th day, intraperitoneal, ongoing) for peritonitis.At the time of this report, the patient remained hospitalized and was recovering from the events.Pd therapy was ongoing.It was reported that the patient retraining on the proper aseptic technique was not done.No additional information is available.
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Manufacturer Narrative
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Additional information: b5 and b6.B5: upon follow-up, it was reported that antibiotic treatment was discontinued (on an unknown date).At the time of this report, the patient was discharged from the hospital and recovered from the events (on an unknown date).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction, g3: date received by mfr: the initial mdr g3 date was inadvertently submitted as 01/10/2024; however, the correct date is 01/09/2024.Should additional relevant information become available, a supplemental report will be submitted.
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