BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD SOURCE/RS 3000

    MDR report key: 400972 · Received June 6, 2002

    Report

    Report Number
    1063922-2002-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2002
    Date of Event
    May 8, 2002
    Report Date
    June 5, 2002
    Manufacturer
    *
    Product Code
    IYT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE REGULAR QUALITY ASSURANCE PROGRAM IDENTIFIED A POTENTIAL PROBLEM IN ONE RS 3000 BLOOD IRRADIATOR RELATED TO LOW RADIATION OUTPUT OF THE LOWER X-RAY TUBE. THE UNIT WAS IMMEDIATELY TAKEN OUT OF SERVICE. THE DATE AFTER RAD SOURCE RECEIVED THE DOSIMETRY RESULTS FROM THE QA PROGRAM, A COMPANY PHYSICIST WAS ON SITE INVESTIGATING THE UNIT. THE LOW RADIATION OUTPUT WAS CONFIRMED. THIS PROBLEM WAS NOT DETECHED BY THE TUBE CURRENT SENSING FUNCTION OF THE CONTROL SYSTEM. THE CURRENT THROUGH THE TUBE IS NORMAL. THE LOW OUTPUT APPEARS TO BE DUE TO SOME INTERNAL DEFECT IN THE TUBE. THE PROBLEM WAS NOT DETECTED BY THE RAD-SURE XR IRRADIATION INDICATORS ROUTINELY USED BECAUSE THE INDICATORS (WHICH DETECT ONLY 15 GY) WERE PLACED ON THE CENTER OF THE BLOOD BAG ON THE TOP SIDE OF THE CANISTER, CLOSEST TO THE FUNCTIONING TUBE. THIS POINT RECEIVED A DOSE OF 15 GY. THE DOSE DEFICIENCY OCCURRED ON THE BOTTOM SIDE AT THE PERIPHERY OF THE CANISTER, CLOSEST TO THE MALFUNCTIONING TUBE. BECAUSE THE IRRADIATION INDICATOR WAS PLACED IN THE CENTER OF THE CANISTER, IT RECEIVED A SUFFICIENT DOSE, WHILE THE PERIPHERY OF THE CANISTER DID NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAD SOURCE/RS 3000 BLOOD IRRADIATOR IYT * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other