BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 2220327 · Received August 16, 2011

    Report

    Report Number
    1518293-2011-00145
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    March 17, 2011
    Report Date
    July 29, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN AIR INJECTION OCCURRED IN (B)(6) OF 2011. THE CUSTOMER HAS BEEN USING THE INJECTOR SINCE THE INCIDENT AND HAD A RECENT SERVICE VISIT ON (B)(6) 2011. DURING THIS SERVICE VISIT THE FSE REPLACED A DENTED TOP COVER AND VERIFIED PROPER OPERATION OF THE INJECTOR PER SERVICE CHECKLIST (B)(4). NO OTHER MALFUNCTION OF THE INJECTOR WAS REPORTED DURING THE COMPLETION OF THE CHECKLIST. CTS HISTORY SEARCH SHOWS NO OTHER SIMILAR ISSUES WITH THIS UNIT. NO FURTHER INVESTIGATION NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS AN (B)(6) FEMALE EMERGENCY DEPARTMENT (ED) PATIENT HAVING A CT ABDOMEN/PELVIS WITH CONTRAST FOR CROHNS DISEASE. OPTIRAY 350 LOADED INTO AN EMPTY DISPOSABLE SYRINGE. SALINE WAS ALSO LOADED INTO AN EMPTY DISPOSABLE SYRINGE FOR DUAL HEAD INJECTION PROCEDURE. SYRINGES WERE CONNECTED TO THE PATIENT EXISTING IV SITE FROM THE EMERGENCY DEPARTMENT. UNDETERMINED INJECTION PROTOCOL WAS INITIATED BY THE TECHNOLOGIST. TECHNOLOGIST NOTED NO CONTRAST ON THE SCAN IMAGES, AND IMMEDIATELY STOPPED THE CT SCAN AND INJECTION. RADIOLOGIST WERE CALLED TO EVALUATE THE PATIENT AND SCAN IMAGES. RADIOLOGIST DETERMINED A LARGE AIR EMBOLUS (VOLUME NOT SPECIFIED) ON THE SCAN IMAGES. PATIENT WAS NOT DEMONSTRATING ANY SIGNS OR SYMPTOMS OF STRESS. RADIOLOGIST DETERMINED THE PATIENT EXAM COULD BE CONTINUED AND HAND INJECTED CONTRAST MEDIA TO COMPLETE THE PROCEDURE. A FEW MINUTES POST THE PROCEDURE, THE RADIOLOGIST REQUESTED A REPEAT CT SCAN TO EVALUATE THE AIR EMBOLUS AND NOTE THE AIR EMBOLUS HAD RESOLVED. PATIENT WAS RETURNED TO THE EMERGENCY DEPARTMENT.

    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 81 YR Other