BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTER

    MDR report key: 2250787 · Received August 31, 2011

    Report

    Report Number
    2250787
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 31, 2011
    Manufacturer
    MDSS GMBH
    Product Code
    FPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 0.2 MICRON IN-LINE FILTER WAS IN USE ON THE TPN TUBING. IN THE LAST 2 WEEKS, THE FILTER HAS CLOGGED 7 TIMES AND HAD TO BE CHANGED. THIS POSES A RISK OF INFECTION TO IMMUNOCOMPROMISED PATIENTS. A PATIENT WAS ON 4 CARDIOTONIC DRIPS INFUSING WITH THE TPN. THE FILTER HAD TO BE CHANGED AND THE PATIENT'S BLOOD PRESSURE DROPPED REQUIRING AN INCREASE IN THE EPINEPHRINE DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTER 0.2 MICRON FILTER, 9 INCH FPB MDSS GMBH * 2300237

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR CARDIAC DRUGS| OTHER