BEUDAMED
    FDA Adverse Event Other Summary report: N

    STELLANT DUAL CT SYSTEM

    MDR report key: 4692087 · Received April 13, 2015

    Report

    Report Number
    2520313-2015-00021
    Event Type
    Other
    Date Received
    April 13, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE PERFORMED AN INJECTOR CHECKOUT ON (B)(6) 2015 AND THE INJECTOR WAS FOUND TO PERFORM TO SPECIFICATION AND AS INTENDED. THE INJECTOR HAS BEEN IN USE DAILY SINCE THE REPORTED OCCURRENCE. THE ACTUAL DISPOSABLES INVOLVED DURING THE INCIDENT WERE DISCARDED BY THE CUSTOMER AND UNAVAILABLE FOR EVALUATION. LOT NUMBERS OF THE DISPOSABLES IN USER WERE PROVIDED. RETAINED SAMPLES WERE TESTED AND WERE FOUND TO PERFORM TO SPECIFICATION. THE CUSTOMER WAS OFFERED ADDITIONAL APPLICATIONS TRAINING AND HAS DECLINED AT THIS TIME.

    Description of Event or Problem · 1

    A BAYER REPRESENTATIVE REPORTED THE FOLLOWING: A (B)(6) YEAR OLD MALE PATIENT WITH AN ADMITTING DIAGNOSIS OF CHEST PAIN SUFFERED AN ALLEGED 4 ML AIR INJECTION WHILE UNDERGOING A CARDIAC CTA WHEN CONNECTED TO THE STELLANT INJECTOR. THE AIR WAS OBSERVED ON THE IMAGES LOCATED IN THE PULMONARY VESSEL. THE PATIENT WAS ASYMPTOMATIC. IN RESPONSE TO THE AIR VISUALIZED, THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION WITHOUT ANY FURTHER TREATMENT BEING REQUIRED. THE PATIENT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244871 STELLANT DUAL CT SYSTEM CT INJECTION SYSTEM DXT BAYER MEDICAL CARE, INC. 3010432

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization