BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Device Problem
Contamination (1120)
|
Patient Problem
Peritonitis (2252)
|
Event Type
Injury
|
Event Description
|
It was reported that a patient experienced a break in aseptic technique further described as the patient left the window open during peritoneal dialysis (pd) therapy, which caused peritonitis.On an unreported date, the patient was hospitalized for the peritonitis event.The treatment for the peritonitis event was unknown.The patient was discharged from the hospital after four days.The patient recovered from the peritonitis.The pd therapy was ongoing.Additional information was requested but was not available at this time.
|
|
Manufacturer Narrative
|
(b)(4).The date of onset of the peritonitis event was on an unreported date sometime around (b)(6) 2014.As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.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 review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|