BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOGEN-82®

    MDR report key: 13839123 · Received March 21, 2022

    Report

    Report Number
    13839123
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 3, 2022
    Manufacturer
    BRACCO DIAGNOSTIC INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CARDIAC MOLECULAR IMAGING (CMI) COORDINATOR REPORTED THAT A NEW RB-82 GENERATOR WAS RECEIVED. "AFTER THE GENERATOR FAILED TWO QUALITY ASSURANCE TESTS, THE MANUFACTURER WAS NOTIFIED FOR ASSISTANCE." CMI COORDINATOR WORKED WITH BRACCO DIAGNOSTIC INC. ALL DAY MONDAY TO TRY TO FIGURE OUT THE PROBLEM. AFTER FURTHER TESTS AND CHECKS, IT WAS DISCOVERED THAT THE GENERATOR CASE WAS LEAKING FROM UNDERCARRIAGE. ALL CONTAMINATION WAS CONTAINED WITHIN THE DELIVERY SYSTEM OF THE GENERATOR SO THERE WAS NO NEED TO PERFORM ANY SPILL CLEANUP AND THERE WERE EXPOSURE RATE CONCERNS. THE DAMAGED GENERATOR DELIVERY SYSTEM IS CURRENTLY BEING STORED IN THE ¿HOT LAB.¿ WE ARE WORKING TO RETURN THE GENERATOR BACK TO THE MANUFACTURER AND ARE AWAITING INSTRUCTIONS. NO PATIENTS WERE TREATED WITH THIS GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545195 CARDIOGEN-82® SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS BRACCO DIAGNOSTIC INC. 1700 09101-220531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown