BEUDAMED
    FDA Adverse Event Death Summary report: N

    (BASIC) SYSTEM CT9000

    MDR report key: 699775 · Received April 12, 2006

    Report

    Report Number
    1518293-2006-00007
    Event Type
    Death
    Date Received
    April 12, 2006
    Date of Event
    March 10, 2006
    Report Date
    March 27, 2006
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED THROUGH IV WITH AN INJECTOR THAT HAD BEEN LOADED WITH A PREFILLED CONTRAST SYRINGE IN PREPARATION FOR A CT SCAN. AFTER THE CT SCAN, THE PATIENT COMPLAINED OF BREATHING PROBLEMS WHILE STILL LYING ON THE CT TABLE. THE PATIENT LOST CONSCIOUSNESS AND A CODE BLUE WAS CALLED. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM PHYSICIAN WAS NOTIFIED. THE PATIENT EXPIRED LATER THE SAME DAY. IN 06: SPLE WITH CUSTOMER AND REPORT THE FOLLOWING. FEMALE HAVING A CT SCAN OF THE CHEST FOR LUNG CANCER. IV ACCESS WAS A 22GA DEVICE (TYPE UNKNOWN) IN THE RIGHT FOREARM. CONTRAST MEDIA, OPTIRAY 320 (PREFILLED SYRINGE) WAS INJECTED AT AN UNKNOWN RATE AND VOLUME. CUSTOMER REPORTS THAT IVE STARTED AT 9:25. CODE BLUE CALLED AT 935. 911 RESPONDED AT 9:44. PATIENT TRANSPORTED AT 9:58. CTRC PHYSICIAN NOTED AIR ON THE CT SCAN BUT VOLUME OF AIR WAS NOT DETERMINED. IT SHOULD BE NOTED THAT THERE IS A SLIGHT DIFFERENCE IN TYCO HEALTHCARE ADVERSE DRUG EVENT RECORD (T200600119) AND TYCO HEALTHCARE DEVICE RECORD: TYCO HEALTHCARE ADVERSE DRUG REPORT ASSESSMENT RECORDS PATIENT HAD TROUBLE BREATHING AND IMMEDIATELY "SLUMPED" OVER. SAFETY OFFICER COMMENTS AND ORIGINAL CUSTOMER MEDWATCH FORM INDICATE THAT PATIENT WAS STILL "LAYING" ON THE TABLE WHEN SHE LOST CONSCIOUSNESS AND A CODE BLUE WAS CALLED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death