BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6154514 · Received December 8, 2016

    Report

    Report Number
    1416980-2016-18166
    Event Type
    Death
    Date Received
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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 PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS REFERRED TO THE HOSPITAL, BUT DIED IN THE EMERGENCY UNIT DUE TO PERITONITIS. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. ACTION TAKEN WITH PD THERAPY AT THE TIME OF THIS REPORTED EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806938 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H DIANEAL 1.5%| DIANEAL 2.5%