BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX

    MDR report key: 22073778 · Received May 22, 2025

    Report

    Report Number
    9611369-2025-00076
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    April 19, 2025
    Report Date
    May 22, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FJI
    UDI-DI
    07332414102760
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HEMOFILTRATION TREATMENT WITH A POLYFLUX DIALYZER, THE DEVICE GENERATED AN ALARM FOR AN INTERNAL BLOOD LEAK. BLOOD WAS OBSERVED IN THE CIRCUIT AND THE TREATMENT WAS STOPPED; SUBSEQUENTLY, THE DIALYZER WAS DISCARDED. TREATMENT WAS RESTARTED ONE HOUR AND 15 MINUTES LATER. AFTER ONE HOUR OF THERAPY, THE PATIENT EXPERIENCED PROFUSE SWEATING WITH VOMITING, URINARY INCONTINENCE, DISCOMFORT AND SIGNIFICANT WEAKNESS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS MEASURED AT 15.8MMOL/L, THE BLOOD PRESSURE WAS MEASURED AT 190/100 MMHG. IT WAS REPORTED "THE BLOOD WAS RESTORED AND WERE TAKEN OFF THE MACHINE". THE CAREGIVER REQUESTED THE PATIENT TO BE TAKEN FOR OBSERVATION AT THE HEALTH FACILITY. IT WAS FURTHER REPORTED THAT THE PATIENT'S COMFORT IMPROVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220357 POLYFLUX DIALYZER, CAPILLARY, HOLLOW FIBER FJI VANTIVE US HEALTHCARE LLC NA 4-4510-H-01 07332414102760

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention