BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6213545 · Received December 29, 2016

    Report

    Report Number
    1416980-2016-18899
    Event Type
    Death
    Date Received
    December 29, 2016
    Report Date
    December 29, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    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 ACUTE PERITONITIS AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF PERITONITIS AND TREATMENT WERE UNKNOWN. THE PATIENT DIED DUE TO ACUTE PERITONITIS. THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS PRIOR TO THEIR DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864507 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death DIANEAL PD-2 1.5%