BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 2130423 · Received June 14, 2011

    Report

    Report Number
    1518293-2011-00106
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    LIEBEL-FLARSHEIM BUSINESS
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN INFILTRATION OCCURRED DURING AN INJECTION. THERE WAS NO SERIOUS INJURY REPORTED. THE DEPARTMENT SUPERVISOR BELIEVED THE CAUSE OF THE INFILTRATION WAS POOR NEEDLE PLACEMENT BY THE NURSE, AND NOT THE INJECTOR. THE CUSTOMER DID NOT DESIRE TO HAVE A LIEBEL FLARSHEIM SERVICE ENGINEER VISIT TO CHECKOUT THE INJECTOR. NO INJECTOR SERIAL NUMBER WAS REPORTED, BUT A CTS HISTORY SEARCH OF THE INSTITUTION SHOWS NO OTHER INFILTRATIONS HAVE BEN REPORTED BY THIS CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE; (B)(6) Y/O FEMALE PATIENT HAVING A CT CHEST FOR HILAR ENLARGEMENT WITH CONTRAST. OPTIRAY 320 CONTRAST LOADED INTO THE INJECTOR. INJECTION PROTOCOL OF 3ML/SECOND FOR 100ML. IV ACCESS DEVICE WAS A 20GA ANGIOCATH IN THE RIGHT ANTECUBITAL VEIN, ATTACHED TO A BD LEVERLOCK NEEDLELESS VALVE. INJECTION STARTED, BUT NO CONTRAST NOTED ON THE CT IMAGES. STAFF REPORTS APPROXIMATELY 60ML INFILTRATED INTO THE PATIENT'S UPPER ARM. A RADIOGRAPH WAS TAKEN TO DOCUMENT THE AMOUNT OF CONTRAST WITHIN THE PATIENT ARM. SWELLING NOTED AROUND THE SITE. ARM ELEVATED AND WARM PACKS APPLIED. PATIENT OBSERVED FOR APPROXIMATELY 30 MINUTES WHEN SWELLING HAD REDUCED. PATIENT DISCHARGED WITH INSTRUCTIONS TO USE ELEVATION AND WARM COMPRESS AT HOME. PATIENT TO GO TO THE ER IF SHE EXPERIENCES REDNESS, INCREASED PAIN OR SWELLING. CUSTOMER REPORTS THEY DO NOT FEEL THE INJECTOR SYSTEM NEEDS TO BE EVALUATED. DEPARTMENT SUPERVISOR FEELS THE EVENT WAS DUE TO BAD NEEDLE PLACEMENT BY THE RN STARTING THE IV.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention