BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3493072 · Received November 27, 2013

    Report

    Report Number
    1416980-2013-33028
    Event Type
    Injury
    Date Received
    November 27, 2013
    Date of Event
    November 4, 2013
    Report Date
    November 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 REQUIRED HOSPITALIZATION FOR THIS PERITONITIS EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN (1GM ON THE NEXT EXCHANGE THEN EVERY FIFTH DAY) AND FORTUM (1GM IN THE NEXT BAG THEN 250 MG IN EACH EXCHANGE). THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS RECOVERING FROM THIS EVENT AND PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618043 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R DIANEAL 2.5% ULTRABAG