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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 07/11/2014 |
Event Type
Injury
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Event Description
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It was reported that the patient had a break in aseptic technique during peritoneal dialysis (pd) therapy which resulted in peritonitis.The break in aseptic technique was further described as touch contamination.The patient was not hospitalized for the peritonitis.The patient was treated with ancef (2 gram, daily, intraperitoneally) for peritonitis.Treatment with ancef was ongoing.At the time of this report, the patient was recovering from the peritonitis.Dianeal therapies were ongoing.No additional information is available.
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Manufacturer Narrative
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(b)(4).The cause of this peritonitis was use error described as break in aseptic technique.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.A formal 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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Search Alerts/Recalls
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