BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 1243804 · Received November 24, 2008

    Report

    Report Number
    1518293-2008-00359
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    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 MANUFACTURING REPORT: LF FIELD SERVICE ENGINEER EVALUATED THE INJECTOR INVOLVED WITH THE REPORTED EVENT BY CONDUCTING A PERFORMANCE EVALUATION. THE PERFORMANCE EVALUATION IS USED TO VERIFY PERFORMANCE OF THE INJECTOR TO MANUFACTURING SPECIFICATIONS AFTER AN INSTALLATION AND FOR PREVENTIVE MAINTENANCE TESTS. THE PROCEDURE FOLLOWED BY THE FSE IN PERFORMING THE EVALUATION OF THE INJECTOR IS DOCUMENTED IN THE OPTIVANTAGE INJECTOR SERVICE MANUAL, MAINTENANCE SECTION 4.2. THE FSE EVALUATION VERIFIED THAT THE INJECTOR WAS OPERATING WITHIN THE SPECIFIED TOLERANCES AND THAT ALL SAFETY WARNING MESSAGES WERE VERIFIED AND OPERATIONAL. THE CONCLUSION FROM THE EVALUATION IS THAT THE REPORTED EVENT IS NOT ATTRIBUTABLE TO THE INJECTOR. INJECTOR SYSTEM WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS ON THE DAY BEFORE, A FEMALE ER PATIENT HAVING A CT ABD WITH CONTRAST FOR PAIN. IV ACCESS WAS THE LEFT AC WITH AN UNKNOWN TYPE OF ACCESS DEVICE OR SIZE (PLACED BY ER STAFF). A PREFILLED OPTIRAY 320, 100ML CONTRAST SYRINGE (UNKNOWN LOT AND EXP DATE) AND PREFILLED SALINE (UNKNOWN LOT AN EXP DATE) SYRINGE WAS LOADED INTO THE INJECTOR DUAL HEAD FACEPLATES. SYRINGES CONNECTED BY A COILED "Y" TUBING TO AN INSYTE NEEDLELESS DEVICE TO THE IV ACCESS DEVICE. INJECTION PROTOCOL WAS SET AT 2ML/SEC FOR 95ML CONTRAST VOLUME, AND 2ML/SEC FOR 20ML SALINE VOLUME. APPROXIMATELY 70ML FLUID EXTRAVASATED. PATIENT WAS TREATED WITH ALTERNATING WARM AND COLD COMPRESSES AND PATIENT RETURNED TO THE ER. PATIENT WAS CONSULTED BY A PLASTIC SURGEON. CT DEPARTMENT KNOWS THE PATIENT WAS TAKEN TO SURGERY, BUT DOES NOT HAVE ANY FURTHER INFORMATION.

    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 52 YR Required Intervention