BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1903625 · Received November 17, 2010

    Report

    Report Number
    1903625
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    DURING A TRAUMA THE NURSES WERE PREPARING TO USE A RAPID INFUSER, BUT THEY WERE GETTING ERROR ALARMS. THEY WERE ABLE TO SETUP A SECOND INFUSER. THERE WAS NO PATIENT HARM AND ULTIMATELY THE INFUSER WAS NOT USED OR NEEDED. AFTER FURTHER INSPECTION WE FOUND A DEFECT IN THE TUBING OF THIS DISPOSABLE SET. THE DEFECT IS LOCATED IN THE TUBING THAT LEADS TO THE PATIENT. THERE IS A SECTION ABOUT 1/2 OF AN INCH LONG WHERE THE TUBING WALLS ARE TWISTED AND FLATTENED. THIS DEFECT CAUSED AN OCCLUSION AND A HIGH PRESSURE ALARM.====================== HEALTH PROFESSIONAL'S IMPRESSION============================================ MANUFACTURER RESPONSE FOR HEATED RAPID INFUSER, (BRAND NOT PROVIDED)======================THIS SET WAS SENT BACK TO BELMONT FOR THEIR EVALUATION TODAY. (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HEATED RAPID INFUSER KZD BELMONT INSTRUMENT CORPORATION * NOT SURE.

    Patients

    Seq Age Sex Outcome Treatment
    1 *