(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 breach in aseptic technique which resulted in peritonitis coincident with peritoneal dialysis (pd) therapy.The breach in aseptic technique was further described as the patient did not wash their hands during pd therapy.Peritonitis was manifested by cloudy effluent, nausea, vomiting and not feeling well.On the same day as the onset of peritonitis, the patient was hospitalized.The patient was treated with vancomycin (route, dose, and frequency not reported, duration of five days) and gentamycin (route, dose, and frequency not reported, duration of five days) for peritonitis.Dianeal and extraneal therapies were ongoing.At the time of this report, the patient was recovered from the event and discharged from the hospital (total stay of five days).On an unreported date, the patient was retrained on proper aseptic technique.No additional information is available.
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