BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 1960777 · Received December 17, 2010

    Report

    Report Number
    2916710-2010-00144
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THE EVENT IS RELATED TO HUMAN/EQUIPMENT INTERFACING: USER TRAINING DEFICIENCY. THERE IS AN AGREEMENT BETWEEN VARIAN AND CUSTOMER SITE THAT EXTERNAL ID WOULD BE ALWAYS UNIQUE. HOWEVER, AN UNK ERROR AT CUSTOMER END LED TO THE CREATION OF DUPLICATE EXTERNAL ID. THE FOLLOWING ROOT CAUSE WAS IDENTIFIED: ERROR IN THIRD PARTY PROVIDED UNIQUE ID DATA. IT HAPPENED AFTER THE INITIAL SOFTWARE INSTALLATION, AT A LATER POINT OF TIME. LIMITED MATCHING CHOICES PROVIDED BY THE CUSTOMER SITE. PT DATA IMPORT FROM EXTERNAL DATABASES, THAT MATCH PT FILES BY FIRST NAME, LAST NAME AND NON-UNIQUE EXTERNAL ID, CAN LEAD TO A MISMATCH OF PT DATA FILES. IF INCORRECT PT DATA HISTORY IS USED AS THE BASIS FOR THE TREATING PHYSICIAN'S TREATMENT PLAN, SUBOPTIMAL TREATMENT COULD RESULT. MOST SERIOUS SCENARIO WOULD BE THE USE OF THE LOWER PRESCRIBED DOSE OR PARTIAL TREATMENT OF KNOWN DISEASE, BASED ON THE INCORRECT HISTORY THAT TREATMENT HAD BEEN PREVIOUSLY DELIVERED. MOST LIKELY, UNDER DOSE OF THE TARGET VOLUME COULD RESULT IN LOSS OF TUMOR CONTROL, LEADING TO DISEASE PROGRESSION, REQUIRING MEDICAL INTERVENTION. NO ADDITIONAL F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    A PT'S RECORD WAS INCORRECTLY UPDATED BECAUSE THE CUSTOMER HAD THE WRONG PT ID IN ARIA ON A MANUALLY CREATED PT. NO SERIOUS INJURY TO THE PT WAS REPORTED. NO OTHER PT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS HIT

    Patients

    Seq Age Sex Outcome Treatment
    1