BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE, ROLL AROUND INJ SYSTEM

    MDR report key: 3884254 · Received May 20, 2014

    Report

    Report Number
    1518293-2014-00054
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY
    Product Code
    DXT
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED AND REPORTS THAT HE WAS NOT ABLE TO DUPLICATE THE EVENT. FSE PERFORMED A SYSTEM CHECKOUT ACCORDING TO SERVICE CHECKLIST, USING SERVICE MANUAL. AFTER TESTING, FSE STAYED AND OBSERVED TWO OF THE SAME KIND OF CASES THAT WERE BEING DONE WHEN THE REPORTED UNCOMMANDED INJECTION OCCURRED. BOTH CASES WENT WITHOUT INCIDENT. THE UNIT WAS RETURNED TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THEY WERE DOING A BREAST MRI ON A (B)(6) Y/O FEMALE PT WHEN THE A SIDE INJECTED 20 ML GADOLINIUM UNCOMMANDED. THE INJECTOR WAS LOADED WITH 50 ML PREFILLED SALINE SYRINGE ON THE B SIDE AND A 20 ML PREFILLED CONTRAST SYRINGE ON THE A SIDE. THEY WERE ACTIVELY PERFORMING A DRIP MODE ON THE B SIDE AT THE TIME OF THE INCIDENT, WHEN THEY NOTICED THAT THE A RAM WAS ALL THE WAY FORWARD TO 1 ML AND THE CONSOLE WAS IN THE RESULTS SCREEN. THE TECHNOLOGIST STATES SHE HAD PROGRAMMED THE INJECTOR CONSOLE BUT HAD NOT INITIATED THE INJECTION OR TOUCHED ANYTHING ON THE INJECTOR. THE PT HAD TO WAIT AN HOUR AND THEN THE EXAM WAS DONE IN THE OTHER ROOM SO SHE RECEIVED AN ADD'L 20 ML OF GADOLINIUM AND MRI SCAN. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298636 ELITE, ROLL AROUND INJ SYSTEM DXT LIEBEL-FLARSHEIM COMPANY ELITE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR