BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT9000 ANGIOMAT INJECTOR

    MDR report key: 5310123 · Received September 7, 2004

    Report

    Report Number
    1518293-2004-00011
    Event Type
    Other
    Date Received
    September 7, 2004
    Date of Event
    July 29, 2004
    Report Date
    August 3, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    MAV
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER MADE A VISIT TO THIS FACILITY ON 08/31/2004. FSE NOTES ON SERVICE DISPATCH FORM THAT HE CHECKED PROPER FILL/EXPEL SEQUENCE, VERIFIED SOFTWARE FUNCTIONS AND DID NUMEROUS TEST INJECTIONS. THE UNIT WAS DETERMINED TO BE FREE OF DEFECTS AND IS SAFE FOR PT USE.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT UNDERWENT A CT CHEST/ABDOMEN/PELVIS. THERE WAS GOOD CONTRAST ENHANCEMENT SEEN ON THE IMAGES. WHEN THE RADIOLOGIST WAS READING THE FILMS, A SMALL AMOUNT OF AIR WAS SEEN IN THE SUBCLAVIAN, INNOMINATE AND HEART. THE AMOUNT OF AIR WAS ESTIMATED AT 5CC. THE PT EXPERIENCED NO SYMPTOMS, EITHER DURING OR AFTER THE PROCEDURE. HER PRIMARY CARE PHYSICIAN CONTACTED HER LATER IN THE DAY AND SHE WAS STILL SYMPTOM FREE. THE HOSPITALS INTERNAL BIOMED CHECKED THE INJECTOR - LF CT 9000. ADDENDUM 08/09/2004: PT HISTORY: GASTRIC MASS; FURTHER FOLLOW-UP OF THE PT 3 DAYS POST PROCEDURE FOUND HER TO REMAIN SYMPTOM-FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ANGIOMAT INJECTOR ANGIOGRAPHIC INJECTOR AND SYRINGES MAV LIEBEL-FLARSHEIM CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other