BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 21541081 · Received March 6, 2025

    Report

    Report Number
    1416980-2025-01010
    Event Type
    Death
    Date Received
    March 6, 2025
    Report Date
    March 6, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY PD EFFLUENT, ABDOMINAL PAIN AND DISCOMFORT. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED AND TREATED WITH VANCOMYCIN INJECTION (1GM, INTRAPERITONEAL, EVERY 5TH DAY, ONGOING) AND CEFTAZIDIME INJECTION (1GM, INTRAPERITONEAL, ONCE DAILY, ONGOING) FOR PERITONITIS. THE PATIENT WAS RECOVERING FROM THE EVENTS. ON AN UNKNOWN DATE, THE PATIENT SUBSEQUENTLY PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST. THE PD THERAPY WAS ONGOING TILL 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
    799936 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Death| R| H DIANEAL 1.5% PD2 CAPD| DIANEAL 2.5% PD2 CAPD| UNKNOWN PD CATHETER| UNKNOWN VANTIVE PD DISPOSABLES