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Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Abdominal Pain (1685); Weakness (2145); Peritonitis (2252)
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Event Date 06/30/2014 |
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 resulting in bacterial peritonitis.The peritonitis was manifested by abdominal pain, cloudy effluent and weakness.It was not reported if the patient was hospitalized for the event.The patient was treated with cefazolin (1gram, daily, for 13 days, route not reported) for peritonitis.The patient was retrained on aseptic technique and was recovering from the peritonitis.Dianeal therapy was 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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