(b)(4).This report is for a breach in aseptic technique which 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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It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis therapy, resulting in peritonitis.The breach in aseptic technique was not further identified.On the same day as the event onset, the patient was hospitalized for peritonitis.The patient was initially treated with ceftazidim (dose, route, frequency, and duration not reported) and cefamezine (dose, route, frequency, and duration not reported) for peritonitis.On an unknown date, the antibiotics were changed to ceftazidime (dose, route, frequency, and duration not reported) and vancomycin (dose, route, frequency, and duration not reported) for peritonitis.Physioneal and extraneal therapies remained ongoing.At the time of this report, the patient remained hospitalized; however, the patient had recovered from the peritonitis event.On an unknown date, the patient was retrained on proper aseptic technique.No additional information is available.
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