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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 Date 06/16/2014 |
Event Type
Injury
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Event Description
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It was reported that a patient (pt) had a break in aseptic technique during peritoneal dialysis (pd) therapy which caused peritonitis.The break in aseptic technique was further described as pt made mistake/touch contamination.Eight days later, the patient was hospitalized for the event.On an unreported date, the patient was received unspecified treatment (dose, frequency and route not reported) for the event.At the time of this report, pd therapy was discontinued and the patient had not recovered from the peritonitis event.Additional information was requested but is not available.
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Manufacturer Narrative
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Complaint no: (b)(4).The cause of this peritonitis was use error reported to be due to a break in aseptic technique by the patient.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.If there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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