BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 975936 · Received January 7, 2008

    Report

    Report Number
    1518293-2007-00027
    Event Type
    Injury
    Date Received
    January 7, 2008
    Date of Event
    December 11, 2007
    Report Date
    December 10, 2007
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM SVC REPORT: FIELD SVC ENGINEER DID OPERATIONAL CHECKOUT PER PROCEDURE IN SERVICE MANUAL AND PRESSURE LIMITING TESTING. FSE FOUND ALL INJECTOR FUNCTIONS WITHIN MFG SPECIFICATION. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, "FEMALE OUTPATIENT HAVING A CT SCAN OF ABD/PELVIS WITH CONTRAST FOR RLQ PAIN. IV ACCESS WAS RT AC, WITH 20 GA B-D ANGIOCATH AND CAPPED WITH A B BRAUN SAFE LITE NEEDLESS SYSTEM. OPTIRAY 320 100ML PREFILLED SYRINGE LOADED INTO THE INJECTOR AND CONNECTED TO PT WITH COVIDIEN "Y" COILED TUBING. INJECTION PROTOCOL: 2.3ML PER SEC FOR 96ML VOLUME. AFTER APPROX 10ML THE TECHNOLOGIST NOTICED THAT THE IV INFILTRATED, INJECTION STOPPED. WARM AND COLD COMPRESSES WERE APPLIED ON A ROTATING BASIS. PT OBSERVED FOR 20 MINUTES, THEN DISCHARGED WITH INSTRUCTIONS TO MAINTAIN COMPRESSES AND TO REPORT BACK IF EXPERIENCING ANY PROBLEMS. CUSTOMER ALSO STATES, "THAT THEY FEEL THE IV VEIN ACCESS WAS POOR AND CAUSE OF THE EVENT."

    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 15 YR Required Intervention