BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6063532 · Received October 28, 2016

    Report

    Report Number
    1416980-2016-16740
    Event Type
    Death
    Date Received
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS THERAPY PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. TREATMENT RENDERED FOR THE PERITONITIS EVENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED AND IT WAS NOT REPORT IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT PRIOR TO DEATH. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716557 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O DIANEAL (2.5%)