BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Peritonitis (2252)
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Event Date 11/20/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a patient experienced a breach in aseptic technique which resulted in peritonitis coincident with peritoneal dialysis therapy.The breach in aseptic technique was further described as the patient made mistake/touch contamination.On an unreported date, the patient was hospitalized for the event of peritonitis.On an unreported date, the patient began treatment with unspecified antibiotics.Dianeal therapy was ongoing.At the time of this report, the patient was recovering from this peritonitis event and was "feeling better with antibiotics." it was not reported if the patient was retrained on the proper aseptic technique.No additional information is available.
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Search Alerts/Recalls
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