BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 1990911 · Received February 8, 2011

    Report

    Report Number
    1518293-2011-00010
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER VERIFIED PROPER OPERATION AND INJECTOR CALIBRATION PER OPTIVANTAGE DH SERVICE MANUAL. THE FSE FOUND INJECTOR WORKING ACCORDING TO MANUFACTURER SPECIFICATIONS AND COULD BE USED NORMALLY. INJECTOR RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON 01/17: CUSTOMER REPORTED VIA TELEPHONE, A (B)(6) MALE PT WAS INJECTED WITH AIR WHILE UNDERGOING A COMPUTED TOMOGRAPHY ANGIOGRAM FOR ELECTROPHYSIOLOGY PLANNING. IV ACCESS SITE: LEFT AC, IV ACCESS DEVICE: 18GA NEEDLE WITH BD ALLIGATOR CLAMP CONNECTED TO CONTRAST AND SALINE VIA Y-TUBING. INJECTION PROTOCOL 5ML/SEC FOR 100ML CONTRAST, 75ML SALINE. DISPOSABLE EMPTY SYRINGE FILLED WITH OPTIRAY 350. A FEW SECONDS AFTER THE INJECTION STARTED, TECHNOLOGIST NOTED A BLACK STREAK IN THE UPPER PART OF THE HEART AND STOPPED THE INJECTION. PT WAS ROLLED ON HIS LEFT SIDE AND GIVEN OXYGEN 4L/MINUTE. PT'S VITAL SIGNS WERE MONITORED BY A PHYSICIAN. PT WAS OBSERVED FOR 10-15 MINS. PHYSICIAN CONFIRMED GOOD AIR EXCHANGE AND PERFORMED A CT CHEST, AIR HAD RESOLVED. PT DID NOT EXHIBIT ANY SYMPTOMS AND WAS DISCHARGED. PHYSICIAN REPORTS THEY BELIEVE 40-50ML OF AIR WAS INJECTED INTO THE PT.

    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 54 YR Required Intervention