BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23384460 · Received October 24, 2025

    Report

    Report Number
    3030306055-2025-00427
    Event Type
    Death
    Date Received
    October 24, 2025
    Date of Event
    September 27, 2025
    Report Date
    October 24, 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. IT WAS FURTHER REPORTED THE PATIENT "SEEM TO BE SUFFERING FROM SUSPECTED PERITONITIS"; HOWEVER, THIS WAS NOT CONFIRMED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH AN INJECTION CEFTAZIDIME (1GM, INTRAPERITONEAL, ONCE A DAY), INJECTION VANCOMYCIN (1GM, EVERY 3RD DAY, INTRAPERITONEAL) AND INJECTION HEPARIN (2000IU 2ML, ONCE A DAY, INTRAPERITONEAL) FOR SUSPECTED PERITONITIS. THREE DAYS AFTER THE PERITONITIS ONSET, THE PATIENT PASSED AWAY WHILE HOSPITALIZED. THE CAUSE OF DEATH WAS REPORTED AS DUE TO ¿FISTULA BURST¿. IT IS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM PERITONITIS. IT WAS REPORTED THAT THE PD THERAPY WAS ONGOING TILL DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046628 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Death| R| H CATHETER MANUFACTURER NAME - UNKNOWN.| DIANEAL 2.5% PD2.| UNKNOWN VANTIVE DISPOSABLE PRODUCTS.