(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 bacterial peritonitis coincident with continuous ambulatory peritoneal dialysis (capd) therapy.The breach in aseptic technique was further described as the patient did not wear a mask.Peritonitis was manifested by diarrhea, vomiting, and cloudy effluent.On the day of onset, the patient was hospitalized for the bacterial peritonitis.On an unreported date, the patient began treatment with unspecified antibiotics (route, medication, dosage, frequency, and duration not reported) for the bacterial peritonitis.Dianeal therapies were ongoing.The patient was recovering from the bacterial peritonitis.On an unreported date, the patient was retrained on the proper aseptic technique.No additional information is available.
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(b)(4).Upon follow up it was reported the twenty-three days after the peritonitis onset, the patient was discharged from the hospital and was recovered from this peritonitis event.Should additional relevant information become available, a supplemental report will be submitted.
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