BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE

    MDR report key: 1578423 · Received January 11, 2010

    Report

    Report Number
    MW5014342
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 24, 2009
    Report Date
    January 11, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DRAW BACK OF ISOVUE CONTRAST INTO THE CT CONTRAST INFUSION PUMP SYRINGE, AIR WAS BEING DRAWN IN AROUND THE SYRINGE PLUNGER SUBJECTING PT TO THE POSSIBILITY OF AIR INJECTION. AIR WAS DISCOVERED AND PURGED OUT OF THE SYSTEM PRIOR TO BEGINNING THE INFUSION, SO THERE WAS NO INJECTION OF AIR INTO THE PT'S VEIN, THEREFORE, NO ADVERSE OUTCOME TO PT. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: CAT SCAN CONTRAST FOR IMAGING STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE OPTIVANTAGE CT DUALPACK SYRINGES IZQ LIEBEL-FLARSHEIM CO. 9310040

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR