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); Fatigue (1849); Peritonitis (2252)
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Event Date 01/17/2024 |
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 severe weakness, cloudy pd fluid and abdominal pain.A day prior to the peritonitis diagnosis, the patient was hospitalized due to another indication.The patient was treated with vancomycin injection (1gm, intraperitoneal, every 72 hourly, ongoing), ceftazidime injection (1gm, intraperitoneal, once daily, ongoing) and fluconazole tablet (150mg, oral, once daily, 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 was retrained on the proper aseptic technique.No additional information is available.
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Manufacturer Narrative
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Additional information: b5, b6 and b7.B5: upon follow-up, it was reported that antibiotic treatment was discontinued (on an unknown date).On an unknown date, the pd catheter was removed, pd therapy was discontinued and the patient was transferred to hemodialysis.At the time of this report, the patient has recovered from abdominal pain; however, was recovering from peritonitis, severe weakness, abdominal pain and cloudy pd fluid.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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