BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 22556572 · Received July 21, 2025

    Report

    Report Number
    3030306055-2025-00114
    Event Type
    Death
    Date Received
    July 21, 2025
    Report Date
    July 21, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B2 DATE OF DEATH: IT WAS REPORTED THAT THE PATIENT "PASSED FIRST WEEK ON (B)(6) 2025". B3 DATE OF EVENT: IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL FROM ON (B)(6) 2024 DUE TO SEPTICEMIA. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED THE 3RD ROUND OF PERITONITIS AND PASSED AWAY THE FIRST WEEK ON (B)(6) 2025. H11: 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 "3RD ROUND OF PERITONITIS". THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS INTRAVENOUSLY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPTICEMIA AND HAD BEEN IN THE HOSPITAL ABOUT 7 MONTHS AND PASSED AWAY. IT WAS NOT REPORTED IF THE PERITONITIS WAS RESOLVED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING PRIOR TO DEATH OR AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725332 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death NI.