BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 7123038 · Received December 15, 2017

    Report

    Report Number
    1416980-2017-09840
    Event Type
    Death
    Date Received
    December 15, 2017
    Date of Event
    November 19, 2017
    Report Date
    December 15, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH INJECTION OF VANCOMYCIN (1GM, EVERY FIVE DAYS, ROUTE AND DURATION NOT REPORTED), INJECTION OF FORTUM (1GM, DAILY, ROUTE AND DURATION NOT REPORTED), AND INJECTION OF HEPARIN (0.5ML, DURATION AND ROUTE NOT REPORTED) FOR PERITONITIS. NINE DAYS AFTER THE ONSET OF PERITONITIS, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS DUE TO CARDIAC ARREST. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. AT THE TIME OF DEATH PD THERAPY WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901450 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| R DIANEAL PD2 2.5%| EXTRANEAL