BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX

    MDR report key: 4091547 · Received July 24, 2014

    Report

    Report Number
    4091547
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 24, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT TREATMENT STARTED WITHOUT DIFFICULTY. ABOUT 25-30 MINUTES INTO THE TREATMENT PCT NOTED THAT WE HAD A SMALL AMOUNT OF BLOOD DRIPPING FROM THE DIALYZER ONTO THE FLOOR. BLOOD COULD BE SEEN IN THE THREADED AREA OF THE HEAD OF THE DIALYZER. NO BLOOD LEAK DETECTED BY THE MACHINE, AND NO SALINE LEAKED DURING THE RECIRCULATION OF THE SYSTEM. AT THE TIME THE STAFF NOTICED DROPS OF BLOOD ON THE FLOOR THERE WAS NO ACTIVE BLOOD DRIPPING. RETURNED PATIENT'S BLOOD AND CHANGED OUT THE DIALYZER. SET SYSTEM BACK UP, AND RESTARTED THE PATIENT'S TREATMENT. RUNNING WITH NO NEW PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433045 OPTIFLUX DIALYZER KDI FRESENIUS MEDICAL CARE 200NR 14AU040009

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR