BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23346867 · Received October 21, 2025

    Report

    Report Number
    3030306055-2025-00417
    Event Type
    Death
    Date Received
    October 21, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 7, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY PD EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE SAME DAY AS PERITONITIS ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH INJECTION AMIKACIN (100MG STAT, INTRAPERITONEAL, ONE DOSE), INJECTION VANCOMYCIN (1GM STAT, INTRAPERITONEAL, ONE DOSE) FOR PERITONITIS. THE FOLLOWING DAY, THE PATIENT WAS TREATED WITH INJECTION MEROPENEM (500 MG. TWICE A DAY, INTRAPERITONEAL, ONGOING) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND THE PATIENT WAS RECOVERING FROM PERITONITIS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355574 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death| R| H DIANEAL 2.5% PD2| EXTRANEAL 7.5% PD2| PD CATHETER COVIDIEN| UNKNOWN VANTIVE DISPOSABLE PRODUCTS