BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 975935 · Received January 7, 2008

    Report

    Report Number
    1518293-2007-00026
    Event Type
    Injury
    Date Received
    January 7, 2008
    Date of Event
    December 6, 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 SERVICE 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

    ON 12/11: CUSTOMER REPORTS, "MALE OUTPATIENT HAVING A CTA SCAN WITH CONTRAST FOR CORONARY DISEASE. IV ACCESS WAS RT AC, WITH 18 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: TEST INJECTION WAS 5ML PER SEC FOR 10ML VOLUME CONTRAST, THEN 5ML PER SEC FOR 50 ML SALINE. IN THE MIDDLE OF THE SALINE STEP OF THE TEST INJECTION, THE IV INFILTRATED. UNK VOLUME, BUT ARM WAS ELEVATED WITH WARM AND COLD COMPRESSES APPLIED AND ROTATED EVERY 15 MINUTES FOR ONE HOUR. PT WAS DISCHARGED WITH INSTRUCTIONS TO MAINTAIN COMPRESSES AND REPORT IF ANY FURTHER EVENT. PT HAS NOT REPORTED ANY FURTHER EVENT." 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 67 YR Required Intervention