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Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Bacterial Infection (1735); Fever (1858); Peritonitis (2252)
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Event Date 06/16/2014 |
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 touch contamination.The peritonitis was manifested by fever.The same day, the patient was hospitalized for the peritonitis event.The peritonitis event was not medically confirmed.The patient was treated prophylactically with cefazolin intraperitoneally (ip) for 21 days (done not reported) for peritonitis.Two days after admission to the hospital, the patient was discharged.The care giver (cg) was retrained on proper aseptic technique as a precaution.Pd therapy was ongoing.At the time of this report, the patient was recovering from the 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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