BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 1045720 · Received May 15, 2008

    Report

    Report Number
    1518293-2008-00177
    Event Type
    Injury
    Date Received
    May 15, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MFG REPORT FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE CHECKLIST PER OPTIVANTAGE INJECTOR SERVICE MANUAL, P/N 844962. FSE PERFORMED SEVERAL INJECTIONS AND VERIFIED PROPER OPERATION. INJECTOR WORKING ACCORDING TO MFR SPECIFICATIONS. INJECTOR RETURNED TO FULL SERVICE BY CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MALE HAVING A CT OF THE CHEST WITH CONTRAST. IV ACCESS WAS A 18GA ANGIOCATH IN THE AC (UNK LT OR RT). OPTIRAY PREFILLED SYRINGE WAS LOADED INTO THE INJECTOR (UNK CONCENTRATION, LOT NUMBER OR EXPIRATION DATE. SYRINGES DISCARDED.) INJECTION PROTOCOL WAS 3.5 ML/SEC FOR A VOLUME OF 100ML. DURING THE INJECTION, APPROX 15ML EXTRAVASATED. PT WAS TREATED WITH A WARM COMPRESS AND OBSERVED FOR 20 - 30 MINS, THEN DISCHARGED WITH NO FURTHER ADE OR INSTRUCTION BY CUSTOMER.

    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 70 YR Required Intervention