BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23051590 · Received September 15, 2025

    Report

    Report Number
    3030306055-2025-00268
    Event Type
    Death
    Date Received
    September 15, 2025
    Date of Event
    August 9, 2025
    Report Date
    September 15, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    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. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED 22 DAYS AFTER ONSET OF PERITONITIS. THE PATIENT RECEIVED UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. SUBSEQUENTLY, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF PATIENT RECOVERED OR WAS RECOVERING FROM THE PERITONITIS PRIOR TO DEATH. IT WAS UNKNOWN IF PD THERAPY WAS ONGOING PRIOR TO DEATH OR AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519253 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| H| R DIANEAL 2.5%.