BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23036845 · Received September 12, 2025

    Report

    Report Number
    3030306055-2025-00258
    Event Type
    Death
    Date Received
    September 12, 2025
    Report Date
    September 12, 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 THE PATIENT WAS HOSPITALIZED AND TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER HOSPITAL ADMISSION. IT WAS REPORTED THAT 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 THE PERITONITIS WAS RESOLVED PRIOR TO DEATH. IT WAS UNKNOWN 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
    2676281 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| D| R DIANEAL 1.5%