BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 2051152 · Received April 5, 2011

    Report

    Report Number
    1518293-2011-00068
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGED NO MALFUNCTION OR DEFECT OF THE INJECTOR AND STATED THE CAUSE OF THE INFILTRATION WAS THE TECHNOLOGIST'S TECHNIQUE. THE CUSTOMER DID NOT WANT THE INJECTOR TO BE CHECKED BY SERVICE. CTS HISTORY SHOWS ANOTHER INFILTRATION REPORTED ON THIS UNIT, ON THE SAME DAY, WHICH WAS ALSO CLAIMED TO BE CAUSED BY TECHNOLOGIST TECHNIQUE. NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 1

    ON 3/24: CUSTOMER REPORTS (B)(6) Y/O MALE HAVING A CT ABDOMEN WITH CONTRAST. OPTIRAY 300 100ML PREFILLED SYRINGE LOADED INTO INJECTOR. PATIENT IV ACCESS 22GA INTIMA IN THE LEFT AC, CONNECTED BY LOW PRESSURE COILED TUBING. INJECTION PROTOCOL OF 2.0ML/SECOND FOR 95ML. IMMEDIATELY AFTER THE ADMINISTRATION OF OPTIRAY THE PATIENT EXPERIENCED SWELLING AT THE LEFT AC INJECTION SITE. CUSTOMER REPORTS APPROXIMATELY 30ML OF THE CONTRAST INFILTRATED THE SITE. THE PATIENT WAS TREATED WITH A HOT PACK TO THE AREA AND A COMPRESSION BANDAGE. STAFF CONTACTED THE PATIENT ON 3/19, THE OUTCOME OF THE EVENT IS REPORTED AS RECOVERED. CUSTOMER REPORTS THE EVENT WAS CAUSED BY TECHNIQUE OF THE TECHNOLOGIST STARTING THE IV. THEY DO NOT FEEL THE INJECTOR SYSTEM INDIRECTLY OR DIRECTLY CAUSED THE EVENT. CUSTOMER DOES NOT FEEL THE INJECTOR SYSTEM NEEDS TO BE EVALUATED BY SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention OPTIRAY 300: 100ML PREFILLED SYRINGE