BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6047744 · Received October 21, 2016

    Report

    Report Number
    1416980-2016-16526
    Event Type
    Death
    Date Received
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS PARTIALLY TREATED WITH ORAL ANTIBIOTICS (FURTHER DETAILS NOT REPORTED) FOR THE PERITONITIS EVENT AND PD EFFLUENT WAS REPORTED AS CLEAR. IT WAS REPORTED THAT THE PATIENT SUBSEQUENTLY PASSED AWAY DUE TO AN UNRELATED MEDICAL CONDITION. IT WAS NOT REPORTED IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS PRIOR TO DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699876 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R EXTRANEAL VIAFLEX