BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6151374 · Received December 7, 2016

    Report

    Report Number
    1416980-2016-18123
    Event Type
    Death
    Date Received
    December 7, 2016
    Date of Event
    November 3, 2016
    Report Date
    March 24, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    PATIENT DIES ON AN UNREPORTED DATE IN (B)(6) 2017. ON AN UNREPORTED DATE IN THE SAME MONTH AS THE MONTH OF PERITONITIS ONSET, THE PATIENT WAS PLACED IN HOSPICE CARE (NOT FURTHER SPECIFIED). TWO MONTHS LATER, ON AN UNREPORTED DATE, THE PATIENT PASSED AWAY DUE TO AN UNREPORTED CAUSE. THE PATIENT WAS IN HOSPICE AT THE TIME OF DEATH (NOT FURTHER SPECIFIED). IT WAS NOT REPORTED IF THE PATIENT RECOVERED FROM THE PERITONITIS EVENT PRIOR TO DEATH. 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 PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE, TREATMENT, AND PATIENT¿S OUTCOME WERE NOT REPORTED. THE ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802028 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H