It was reported that a patient experienced a break in aseptic technique further described as patient made mistake and did not wear a mask during peritoneal dialysis (pd) therapy, which caused peritonitis.Two days after the onset, the patient was treated with injections of ceftazidime (1 gram, twice daily, intraperitoneally (ip)) and injections of vancomycin (2 gram, once daily, ip) for peritonitis.The treatment with the antibiotics was ongoing.The outcome of the peritonitis was not reported.The action taken with pd therapy was not reported.Additional information was requested but was not available at this time.
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Complaint no: (b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.This is a report of a use error that resulted in peritonitis.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.A 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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