BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23063833 · Received September 16, 2025

    Report

    Report Number
    3030306055-2025-00278
    Event Type
    Death
    Date Received
    September 16, 2025
    Report Date
    September 16, 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 WHICH WAS MANIFESTED BY CLOUDY PD EFFLUENT, ABDOMINAL PAIN AND LOSS OF APPETITE. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED AND TREATED WITH AMIKACIN (100MG/ ONCE DAILY/ INTRAPERITONEAL/ ONGOING) AND VANCOMYCIN (1GM/ EVERY 5TH DAY/ INTRAPERITONEAL/ ONGOING) FOR PERITONITIS. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT PASSED AWAY AT THE HOSPITAL. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE SAME PD THERAPY WAS "ONGOING TILL DEATH". NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621449 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Death| R| H CATHETER MANUFACTURER: UNKNOWN.| DIANEAL 2.5% PD2.| UNKNOWN VANTIVE DISPOSABLE PRODUCTS.