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 Type
Injury
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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 further described as improper daily operation.The patient was treated with unspecified anti-inflammatory medications for the event.Hospitalization, patient outcome, and action taken with pd therapy were not reported.It was not reported if the patient was retrained on the proper aseptic technique.The reporter declined to provide additional information.
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Manufacturer Narrative
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B3: the peritonitis occurred on an unspecified date in (b)(6) 2024.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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