BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Peritonitis (2252)
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Event Date 12/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A peritoneal dialysis (pd) patient experienced peritonitis.The cause of peritonitis was unknown.On an unspecified date, the patient was hospitalized for ten days for peritonitis.Approximately a month after the onset, the patient was hospitalized again for peritonitis.It was not reported if the patient received treatment for peritonitis.The patient¿s outcome was not reported.At the time of this report, pd therapy was ongoing.No additional information is available.
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Manufacturer Narrative
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Additional information: b5, h6 and h10.B5: upon follow-up, it was reported that the patient experienced a breach in aseptic technique which resulted in peritonitis.The breach in aseptic technique was further described as poor hygiene.It was not reported if the patient was retrained on the proper aseptic technique.H10: 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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Search Alerts/Recalls
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