BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (BASIC) SYSTEM CT9000

    MDR report key: 1050346 · Received May 22, 2008

    Report

    Report Number
    1518293-2008-00192
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CT DEPT SUPERVISOR STATES, "THEY FEEL THE EVENT IS DUE TO POOR IV SITE POSITIONING AND THE INJECTOR IS WORKING FINE." CUSTOMER DOES NOT WISH TO HAVE THE INJECTOR EVALUATED OR CHECKED BY MANUFACTURING. LIEBEL FLARSHEIM MANUFACTURING REPORT: WHEN COVIDIEN PRODUCT MONITORING CONTACTED THE CUSTOMER CONCERNING THIS EVENT, THE CUSTOMER STATED "THEY FEEL THE EVENT IS DUE TO POOR IV SITE POSITIONING AND THAT INJECTOR IS WORKING FINE." CUSTOMER DID NOT WISH TO HAVE THE INJECTOR EVALUATED OR CHECKED. MANUFACTURING SEARCH OF SERVICE RECORDS SHOW NO SERVICE CALLS CONCERNING THIS UNIT SINCE DEC. 2000.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT A MALE HAVING PE CT SCAN WITH CONTRAST. OPTIRAY 320, 100ML PREFILLED SYRINGE (LOT # P017A, EXPIRATION 02/2010) LOADED INTO INJECTOR. INJECTION PROTOCOL SET AT 3.4 ML/SEC FOR 100ML VOLUME. IV ACCESS WAS THE LT FOREARM WITH A 20 GAUGE ANGIOCATH. INJECTION STARTED AND CT SCAN PERFORMED WITH NO PROBLEMS REPORTED. PT DID NOT EXPRESS PAIN OR DISCOMFORT, BUT TECHNOLOGIST NOTED EXTRAVASATION AT THE IV SITE. ESTIMATED THAT APPROX 25ML OF CONTRAST MAY HAVE EXTRAVASATED. ALL SCAN IMAGES WERE GOOD AND BRIGHT WITH CONTRAST, INDICATING TO THE TECHNOLOGIST THAT THE EXTRAVASATION MUST HAVE OCCURRED AT THE END OF THE INJECTION PROTOCOL. PT TREATED WITH HEATING PAD. DURING FOLLOW UP CALL, THE CUSTOMER STATED, "PT IS DOING FINE. NO SKIN DISCOLORATION, SKIN IS SOFT AND FLAT AT EXTRAVASATION SITE." CUSTOMER STATES, "THEY FEEL THE EVENT IS DUE TO POOR IV SITE POSITIONING AND THE INJECTOR IS WORKING FINE." CUSTOMER DOES NOT WISH TO HAVE THE INJECTOR EVALUATED OR CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (BASIC) SYSTEM CT9000 CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO. CT9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention