BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 1033832 · Received April 25, 2008

    Report

    Report Number
    1518293-2008-00154
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 28, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MFG WAS NOT PROVIDED ANY FURTHER INFO WITH REGARDS TO THIS EVENT. ON 4/9/08, CUSTOMER BIOMED REPORTS THAT THEY HAVE ACTIVATED THE CT9000ADV SAFETY FEATURE AND VERIFIED THAT THE "USED SYRINGE" WARNING IS NOW ACTIVE. ALSO IMPLIED THAT CT EXPERIENCED AN ADVERSE EVENT, AND INDICATED THAT THE SUPV OF THE DEPT HAD EXPRESSED KNOWING IT WAS A USER ERROR AND RETRAINING HAD BEEN PERFORMED. WHEN ASKED IF THEY WOULD LIKE FOR AN LF FIELD SVC ENGINEER TO VISIT AND EVALUATE THE SYS, THE CUSTOMER STATED IT WAS NOT NECESSARY.

    Description of Event or Problem · 1

    ON 3/28: CUSTOMER REPORTS VIA PHONE THAT THEY EXPERIENCED AN AIR INJECTION WITH THE CT9000ADV INJECTOR USING OPTIRAY PREFILLED CONTRAST MEDIA SYRINGE. CUSTOMER ASKS PROD MONITORING TO RETURN CALL ON 03/31/08, THEY WOULD HAVE MORE INFO TO PROVIDE AT THAT TIME. CUSTOMER HAS NOT RETURNED ANY CALLS, NO ADD'L INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV DOMESTIC BASIC SYS CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other