BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX

    MDR report key: 24058864 · Received January 13, 2026

    Report

    Report Number
    9611369-2026-00007
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    October 20, 2025
    Report Date
    January 27, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FJI
    UDI-DI
    07332414102753
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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

    IT WAS REPORTED THAT 10 MINUTES AFTER STARTING TREATMENT WITH POLYFLUX 140H, THE PATIENT EXPERIENCED CHEST TIGHTNESS, SHORTNESS OF BREATH AND SWEATING. TREATMENT WAS STOPPED IMMEDIATELY, AND THE PATIENT WAS ADMINISTERED DEXAMETHASONE (2.5 MG, INTRAVENOUSLY). A DIFFERENT TYPE OF DIALYZER WAS USED TO CONTINUE THE TREATMENT. APPROXIMATELY ONE HOUR AND 10 MINS AFTER STARTING TREATMENT, THE PATIENT DEVELOPED HYPERTENSION (181/104 MMHG). THE PATIENT'S VITAL SIGNS WERE MONITORED UNTIL TREATMENT WAS COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112732 POLYFLUX DIALYZER, CAPILLARY, HOLLOW FIBER FJI VANTIVE US HEALTHCARE LLC NA 4-5817-H-01 07332414102753

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention NI.