BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3250860 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19940
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH A SINGLE DOSE OF VANCOMYCIN, IP (DOSE NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT UNDERWENT AN ABDOMINAL SURGERY FOR AN UNREPORTED INDICATION. PHYSIONEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN AND THE PATIENT WAS PUT ON HEMODIALYSIS. AT THE TIME OF THE INITIAL REPORT, THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS AND WAS STILL IN THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353357 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R PHYSIONEAL 1.36%| EXTRANEAL 7.5%