BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3191273 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16478
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS A GASTRO-INTESTINAL PROBLEM THAT OCCURRED FOR THE PAST 15 DAYS BEFORE THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH AN INJECTION (INJ.) OF CEFAZOLIN 250MG IN EACH BAG, AN INJ. OF FORTUM 250MG IN EACH BAG AND AN INJ. OF HEPARIN 1000 IU IN EACH BAG FOR THE PERITONITIS. THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289953 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DIANEAL 2.5% ULTRABAG