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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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 effluent.The patient was not hospitalized for the event.On an unknown date, the patient was treated with vancomycin injection (1gm, every 5th day, ongoing) and amikacin injection (250mg, intraperitoneal, once a day, ongoing) for the event.At the time of this report, the patient was recovering from peritonitis.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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B5: upon follow-up, it was reported that on an unknown date, the patient was hospitalized due to the events.Antibiotic treatment with vancomycin injection was discontinued (on an unknown date).The patient was discharged from the hospital and took leave against medical advice (on an unknown date).Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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