BEUDAMED
    FDA Adverse Event Other Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 884029 · Received July 20, 2007

    Report

    Report Number
    1518293-2007-00015
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 16, 2007
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELD SERVICE ENGINEER REPORT: VERIFIED OPTIVANTAGE DH INJECTOR SYSTEM FOR PROPER FUNCTION PER OPTIVANTAGE INJECTOR SERVICE MANUAL, P/N 844962 MAINTENANCE SECTION 4.2. PROVIDED INSERVICE FOR CT DEPARTMENT RN ON SYSTEM OPERATIONS. OPTIVANTAGE DH INJECTOR SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER. GOOD CLINICAL PRACTICE WOULD DICTATE THAT HEALTH PROFESSIONALS USING THE CONTRAST MEDIA INJECTOR SYSTEM CHECK FOR AND PURGE ALL AIR FROM SYRINGE AND TUBING BEFORE INITIALIZING THE INJECTION. THE OPTIVANTAGE DH INJECTOR SYSTEM HAS A VISUAL WARNING MESSAGE ON THE TOP RIGHT HAND CORNER OF THE POWER HEAD AND CONSOLE LED SCREEN THAT STATES, "CHECK FOR AIR IN SYRINGE AND TUBING." THIS MESSAGE IS VISIBLE UNTIL ALL REQUIRED STEPS ARE COMPLETED BY THE HEALTHCARE PROFESSIONAL AND THEY HIT THE ENABLE BUTTON. IF THE APPROPRIATE STEPS HAVE NOT BEEN TAKEN, THE SYSTEM WILL NOT ENABLE AND MESSAGE REMAINS VISIBLE. IF REQUIRED STEPS ARE ACCOMPLISHED, THE SYSTEM WILL ENABLE AND THE MESSAGE AREA THEN TURNS INTO THE "START" BUTTON FOR THE INJECTION PROTOCOL AS ENTERED BY THE CUSTOMER.

    Description of Event or Problem · 1

    MALE HAVING A CT OF THE CHEST WITH CONTRAST. OPTIRAY 320 PREFILLED SYRINGE LOADED INTO THE INJECTOR SYSTEM. CUSTOMER REPORTS, THAT INJECTOR SYSTEM DID NOT ENABLE DUE TO STAFF NOT SELECTING SYRINGE SIZE INITIALLY BEFORE CONNECTING TO PT IV ACCESS. THE CUSTOMER DISCONNECTED COILED TUBING FROM SYRINGE, NOT THE PT IV ACCESS NEEDLESS SYSTEM, REMOVED SYRINGE FROM THE INJECTOR. THE CUSTOMER THEN RELOADED THE SYRINGE INTO THE INJECTOR AND REPEATED APPROPRIATE REQUIRED STEPS OF THE OPTIVANTAGE DH INJECTOR SYSTEM TO INITIALIZE AN INJECTION. THE CUSTOMER THEN ENABLED THE INJECTOR SYSTEM FOR A 2ND TIME. COILED TUBING WAS THEN RECONNECTED TO THE SYRINGE WITH AIR BUBBLES PRESENT, DID NOT PURGE THE AIR FROM THE TUBING AND INJECTED. CUSTOMER CT DEPARTMENT STAFF NURSE OBSERVED THE PT FOR ONE HR POST SCAN, WITH NO ADVERSE EVENT NOTED. CUSTOMER INDICATES THAT APPROX 5-8CC OF AIR WAS INJECTED. OPTIRAY PREFILLED SYRINGE INFORMATION NOT AVAILABLE DUE TO PT VOLUME AND USE OF PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR