BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 1160570 · Received September 11, 2008

    Report

    Report Number
    1518293-2008-00271
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARHSHEIM SERVICE ENGINEER EVALUATED THE INJECTOR AND NOTED THAT THE PRESSURE ON THE A SIDE OF THE INJECTOR WAS SLIGHTLY LOW. THE ORIGINAL REPORT OF UNCOMMANDED MOVEMENT WAS NOT OBSERVED. THE TOUCH SCREEN ASSEMBLY WAS REPLACED AS A PROACTIVE MEASURE, DUE TO THE NATURE OF THE REPORTED COMPLAINT. THE PIVOT POST AND PIVOT POST PIN WERE MISSING AND WERE REPLACED. THE UNIT WAS RE-CALIBRATED AND RETESTED AND NO ABNORMALITIES WERE NOTED. REPAIRS DONE PER PROCEDURE MANUAL AND REFERENCE SERVICE MANUAL. INJECTOR WAS RUN THROUGH BURN-IN TESTING OVERNIGHT AND HAD NO OTHER ISSUES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A FEMALE WAS UNDERGOING A CT OF THE HEAD FOR HEADACHES WHEN THE INJECTOR STOPPED BEFORE INJECTING ANY CONTRAST INTO THE PT. SHE REPORTED THAT THE INJECTOR ERROR HAD OCCURRED AND THAT A SMALL AMOUNT OF THE CONTRAST HAD BACKED UP INTO THE SALINE SIDE OF THE TUBING. WHEN SHE TOUCHED THE INJECTOR CONSOLE TO ACCESS THE ERROR CODE, IT STARTED TO INJECT ON ITS OWN, BUT SHE WAS ABLE TO STOP THE INJECTOR IMMEDIATELY BY HITTING THE STOP BUTTON. SHE REPORTED THAT THE INJECTOR HAD INJECTED 6CC/SEC FOR A TOTAL VOLUME OF 18CC/SEC AT 190 PSI. HER ORIGINAL PROTOCOL WAS 1.4CC/SEC AT 190 PSI. HER ORIGINAL PROTOCOL WAS 1.4CC/SEC FOR A TOTAL AMOUNT OF 195CC. SHE REPORTED THAT THEY WERE INJECTING THROUGH A 24 GAUGE IV NEEDLE AND THAT THERE WERE NO INJURIES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTOR, OPTIVANTAGE DH INJECTOR IZQ LIEBEL-FLARSHEIM CO. 844001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR