BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Peritonitis (2252)
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Event Date 01/15/2024 |
Event Type
Death
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Event Description
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A peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in bacterial peritonitis.The breach in aseptic technique was not further described.A day after the event onset, the patient was hospitalized and treated with vancomycin injection (1000mg, intraperitoneal, every 5th day, ongoing), ceftazidime injection (1000mg, intraperitoneal, once daily, ongoing) and piptaz injection (250mg, intravenous, once daily, ongoing) for peritonitis.At the time of this report, the patient was recovering from the event.Pd therapy was ongoing.The patient was retrained on the proper aseptic technique.No additional information is available.
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Manufacturer Narrative
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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. should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information: b2, b5, b7, h1 and h6.B5: upon follow-up, it was reported that on an unknown date, antibiotic treatment and pd therapy were discontinued, the pd catheter was removed, and the patient was transferred to hemodialysis.It was reported that the patient passed away (unknown date).The cause of death was reported as due to breathlessness.It was not reported if an autopsy was performed.It was reported the patient was not recovered from peritonitis at the time of death.Should additional relevant information become available, a supplemental report will be submitted.
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