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 Problem
Peritonitis (2252)
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Event Date 12/11/2023 |
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 (recovered).It was reported that the patient was not hospitalized for the event.The same day as the event onset, the patient was treated with vancomycin injection (1gm, every 5th day, intraperitoneal, ongoing) and fortum injection (1gm, once daily, intraperitoneal, ongoing) for peritonitis.At the time of this report, the patient was recovering from peritonitis.Pd therapy was ongoing.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: upon follow-up, it was reported that antibiotic treatment was discontinued and the patient has recovered from peritonitis (unknown date).Should additional relevant information become available, a supplemental report will be submitted.
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