BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 22924099 · Received August 29, 2025

    Report

    Report Number
    3030306055-2025-00227
    Event Type
    Death
    Date Received
    August 29, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 29, 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
    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. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND DISCHARGED AFTER 21DAYS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. IT WAS REPORTED THE PATIENT EXPERIENCED SEPTIC SHOCK AND PASSED AWAY ON AN UNSPECIFIED DATE. THE CAUSE OF DEATH WAS DUE TO "SEPTIC SHOCK OF 24HRS". IT IS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THE PERITONITIS WAS RESOLVED PRIOR TO DEATH. 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
    2164337 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| R| H DIANEAL 2.5%| DIANEAL 4.25%