BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR LE, INJECTOR SYSTEM

    MDR report key: 2093388 · Received April 12, 2011

    Report

    Report Number
    1518293-2011-00073
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER VISITED SITE AND FOUND THE THIRD PARTY SERVICE GROUP, TRIMED-X, HAD CLEARED THE SCREEN OF AN INITIALIZATION ERROR 17. FSE TROUBLESHOT FOR THE REPORTED UNCOMMANDED MOVEMENT AND FOUND NO PROBLEM, AND COULD NOT REPRODUCE THE COMPLAINT. THE CUSTOMERS LEAD TECH ALSO REPORTED THAT TRIMED-X SERVICE REP COULD NOT REPRODUCE THE COMPLAINT. THE UNIT WAS VERIFIED FOR PROPER OPERATION PER SERVICE CHECKLIST AND RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): LEAD TECHNOLOGIST REPORTED THAT A (B)(6) FEMALE WAS HAVING AN ABDOMEN MRI WITH CONTRAST. INJECTOR LOADED WITH MAGNAVIST CONTRAST AND NORMAL SALINE. INJECTION PROTOCOL OF 2ML/SECOND, 20ML VOLUME FOR CONTRAST, 2ML/SECOND FOR 20 ML VOLUME SALINE. STAFF DOES NOT USE THE INJECTOR DRIP OR PATENCY MODES. STAFF WILL HAND INJECT PRIOR TO INJECTION PROTOCOL TO ASSURE OPEN IV LINE. TECHNOLOGIST HAD LOADED SYRINGES, PURGED THE LINES, THEN STARTED PREPARING THE PT WHEN THEY NOTICED A PUDDLE ON THE FLOOR. IT WAS NOTED THE A SIDE RAM HAD INJECTED CONTRAST, BUT THE B RAM HAD NOT MOVED. THE INJECTOR WAS RELOADED WITH CONTRAST, THE PT PROCEDURE WAS THEN COMPLETED WITHOUT INCIDENT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISTAR LE, INJECTOR SYSTEM MRI POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. OPTISTAR LE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR