BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3419724 · Received October 18, 2013

    Report

    Report Number
    1416980-2013-28803
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    September 19, 2013
    Report Date
    September 25, 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). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY, WHICH REQUIRED HOSPITALIZATION. THE PATIENT WAS TREATED WITH INJECTIONS OF VANCOMYCIN, 1GM, ONCE IN 4 DAYS, FORTUM 1 GM INTRAPERITONEALLY (IP) OD AND AN INJECTION OF HEPARIN SOS (FREQUENCIES WERE NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT AT THE TIME OF THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535682 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DIANEAL 1.5% AND 2.5% ULTRABAG