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Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Abdominal Pain (1685); Peritonitis (2252)
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Event Date 07/04/2014 |
Event Type
Injury
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Event Description
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It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy which resulted in peritonitis.The peritonitis was manifested by abdominal pain.The break in aseptic technique was further described as the patient did not wash their hands or wear a mask.On an unreported date, the patient was hospitalized for the event.On an unreported date, the patient was treated with vancomycin for peritonitis.The patient was retrained on proper aseptic technique.The patient has recovered from the peritonitis event.It was not reported if pd therapy was ongoing.Additional information was not available.
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Manufacturer Narrative
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Complaint no: cmplnt-(b)(4).The cause of this peritonitis was use error reported to be due to a break in aseptic technique by the patient.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.If there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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