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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 06/28/2014 |
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 break in aseptic technique was further described as the pt made a mistake/touch contamination (patient got lazy and forgot to close the window).The patient was not hospitalized for the event.The patient was treated with unknown antibiotics (dose, frequency and route not reported) and has since completed antibiotic therapy.At the time of this report, the patient was recovered from the peritonitis event and pd therapy was ongoing.Additional information was requested but is not available.
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Manufacturer Narrative
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(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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