BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADPLAN

    MDR report key: 836233 · Received April 9, 2007

    Report

    Report Number
    2914292-2007-00019
    Event Type
    Death
    Date Received
    April 9, 2007
    Report Date
    July 27, 2006
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE CONFORMAL RADIATION THERAPY PROTOCOL APPLIED TO TUMORS OF THE PROSTATE WAS MODIFIED IN VARIAN'S CADPLAN TREATMENT PLANNING APPLICATION IN MID 2004. THE USER'S INTENT WAS TO CHANGE FROM USING STATIC WEDGES TO DYNAMIC WEDGES. THIS CHANGE REQUIRED CHANGING PARAMETERS WITH THE APPLICATION IN ORDER TO GUARANTEE PROPER CALCULATION OF RADIATION INTENSITY. HOWEVER, THESE PARAMETERS MAY NOT HAVE BEEN SET CORRECTLY FOR CERTAIN PATIENTS BY THE USER, AND SUBSEQUENT QUALITY ASSURANCE REVIEW (IF ANY) BY OTHER SITE PERSONNEL DID NOT DETECT THIS DISCREPANCY. AS A RESULT, 23 PATIENTS RECEIVED RADIATION TREATMENT IN EXCESS OF THEIR PRESCRIBED DOSES. THE REPORT CONCLUDED THAT THE ACCIDENT RESULTED FROM A LACK OF AWARENESS OF, OR OVERLOOKING, THE BASIC RULES OF QUALITY ASSURANCE IN RADIOTHERAPY (TRACEABILITY OF PRACTICES, DOSAGE VALIDATION, AND VERIFICATION OF ADEQUATE TRAINING OF PERSONNEL) BY THE USER FACILITY. THERE HAVE BEEN NO REPORTS BY USERS, WITHIN THE REPORT OR OTHERWISE, THAT THE CADPLAN TREATMENT PLANNING SOFTWARE MALFUNCTIONED IN ANY MANNER. REQUESTED THAT VARIAN CONTACT THE TWO RADIOTHERAPY CENTERS WHO ARE USING CADPLAN TREATMENT PLANNING SOFTWARE TO REMIND THEM OF THE IMPORTANCE OF QUALITY CONTROL PROCEDURES IN RADIOTHERAPY AND IN THE SELECTION OF STATIC AND DYNAMIC WEDGES, AS WELL AS VERIFICATION PRIOR TO USE. THIS COMMUNICATION WAS SENT IN OCTOBER, 2006. VARIAN WILL FORWARD SUPPLEMENTAL INFORMATION AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REPORTED THAT 23 PATIENTS RECEIVED A RADIATION DOSE GREATER THAN THE PRESCRIBED DOSE BETWEEN MID 2004 AND MID 2005 AT A HOSPITAL CENTER. SUBSEQUENT PRESS RELEASES STATE THAT OF THESE 23 PATIENTS, ONE IS SAID TO HAVE DIED AS A RESULT OF THE OVERDOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADPLAN TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Death