BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX

    MDR report key: 21447973 · Received February 24, 2025

    Report

    Report Number
    MW5166740
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 18, 2025
    Report Date
    February 19, 2025
    Manufacturer
    FRESENIUS USA MANUFACTURING INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WITHIN ONE MINUTE UPON INITIATION OF THE TREATMENT, NOTICED BLOOD TINGED ON THE TUBING OF THE RED WAND. NO BLOOD LEAK ALARM. IMMEDIATELY STOPPED THE BLOOD PUMP, NO BLOOD RETURN MADE. DISCONNECTED THE LINES FROM THE PATIENT'S PORT AND FLUSHED BOTH PORTS WITH NS TO MAINTAIN PATENCY. MACHINE PULLED FROM THE UNIT, LINES REMOVED. PATIENT MOVED TO A DIFFERENT STATION DUE TO AVAILABILITY OF THE MACHINE. NEW LINE SET UP MADE. CHARGE NURSE AND DR. MADE AWARE. LABS DRAWN AS ORDERED. TREATMENT RESTARTED W/O ANY INCIDENT. NO ADVERSE REACTION FROM THE ABOVE INCIDENT. VS (VITAL SIGNS) STABLE, PATIENT DENIES ANY DISCOMFORT. BIOMEDICAL SERVICES INVESTIGATION FOUND THE FOLLOWING: THE BBRAUN HEMODIALYSIS MACHINE WAS INSPECTION BY DIALYSIS SME (SUBJECT MATTER EXPERT), AND IT WAS CONFIRMED THE DIALYSIS MACHINE WAS FUNCTIONING AS INTENDED. FURTHERMORE, WITH UTILIZATION OF A "BLOOD LEAK DYE" IT WAS CONFIRMED THAT THE FRESENIUS ARTIFICIAL KIDNEY CONSUMABLE INTERMEDIARY WAS THE POINT OF FAILURE. CONSUMABLE SUPPLY = OPTIFLUXF160; LOT # 24HU06002. ONCE THE BBRUAN MACHINE WAS VALIDATED TO BE FUNCTIONING PROPERLY, THE BBRUAN MACHINE WAS RETURNED TO CLINICAL WORKFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472180 OPTIFLUX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI FRESENIUS USA MANUFACTURING INC. F180NR

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention DIALOG ADIMEA