BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Peritonitis (2252)
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Event Type
Injury
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Event Description
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It was reported that a patient experienced a breach in aseptic technique during peritoneal dialysis (pd) therapy, which resulted in peritonitis.The breach in aseptic technique was further described as the patient dropping an unknown line into the toilet.The patient was hospitalized for the event.It was reported that the patient was treated with cipro and an unspecified antibiotic (dose, route and frequency not reported) for the event.On an unknown date the patient was switched to hemodialysis for six weeks and at the time of this report, pd therapy had been restarted and was ongoing.The patient was reported to have recovered from the peritonitis.Additional information was requested but is not available.
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Manufacturer Narrative
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(b)(4).The patient experienced peritonitis on an unreported date in (b)(6) 2013.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 formal 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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Manufacturer Narrative
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(b)(4).Additional information was received from the nurse and the consumer.Should additional relevant information become available, a follow-up will be submitted.
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Search Alerts/Recalls
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