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 Problems
Abdominal Pain (1685); Peritonitis (2252)
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Event Date 07/01/2014 |
Event Type
Injury
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Event Description
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This is a report of a patient who experienced a breach in aseptic technique resulting in peritonitis coincident with continuous ambulatory peritoneal dialysis (capd) therapy.The peritonitis was manifested by cloudy effluent and abdominal pain.The breach in aseptic technique was further described as non-compliance.On the same day, the patient was hospitalized for the event of peritonitis.Treatment for the event was not reported.The patient was retrained on aseptic technique.Dianeal therapies were ongoing.At the time of this report, the patient was still hospitalized, and the outcome of the event of peritonitis is unknown.No additional information is available.
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Manufacturer Narrative
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(b)(4).Pt age: the year of the patient's birth was reported to be 1957.The cause of this peritonitis was use error reported to be due to a break in aseptic technique. 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).After 29 days of hospitalization, the patient was discharged from the hospital and reported to have recovered from the peritonitis.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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