BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEVATRON M2/PRIMUS MID-ENERGY

    MDR report key: 2972868 · Received February 21, 2013

    Report

    Report Number
    2910081-2013-01400
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IEC STANDS FOR INTERNATIONAL ELECTROTECHNICAL COMMISSION, AN INTERNATIONAL STANDARDS ORGANIZATION. THE TWO SIEMENS' LINAC SYSTEMS ARE LOCATED AT THE CUSTOMER SITE: SITE 2 MEVATRON M2/PRIMUS MID-ENERGY, MODEL NO. 01940035, SERIAL NO. (B)(4); PRIMUS HI, MODEL NO. 04504200, SERIAL NO. (B)(4). CUSTOMER ADDRESS: (B)(6). THE CUSTOMER HAS REPORTED THAT IT HAS CONTACTED ALL INVOLVED PATIENTS. AT THE CUSTOMER'S REQUEST, ON (B)(4) 2013, A SIEMENS CUSTOMER SERVICE ENGINEER CHANGED THE IMAGING DOSE RATE BACK TO THE ORIGINAL VALUE. THE CUSTOMER VERIFIED THE NEW PARAMETER. THE INCIDENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(4) 2013 OF AN INCIDENT AT THE CUSTOMER SITE INVOLVING THE ADJUSTMENT OF THE PATIENT-POSITIONING IMAGING SYSTEM USED DURING RADIOTHERAPY TREATMENT. PER CUSTOMER REQUEST, THE DOSE RATE FOR FILM MODE ON THE PATIENT-POSITIONING IMAGING SUB-SYSTEM OF TWO SIEMENS' LINAC SYSTEMS WAS CHANGED IN 2010. (IMAGING IS USED TO CONFIRM PATIENT POSITION PRIOR TO THE DELIVERY OF RADIOTHERAPY). ACCORDING TO THE CUSTOMER, ON (B)(6) 2013, THEY DETERMINED THAT THE EXCEL FILE THEY USE FOR CALCULATING THE CORRECT IMAGING DOSE DID NOT REFLECT THE 2010 CHANGE IN THE IMAGING DOSE RATE. THE CUSTOMER REPORTED THAT THERE ARE POTENTIALLY FIFTY (50) PATIENTS WHO RECEIVED RADIOTHERAPY TREATMENT DURING THE 2010 TO (B)(6) 2013 TIME PERIOD IN WHICH THE REPORTED INCORRECT CALCULATION OF THE IMAGING DOSE RATE COULD HAVE RESULTED IN AN INCREASE IN THE CUMULATIVE TOTAL DOSE DELIVERED. (THE IMAGING DOSE IS ADDED TO THE TREATMENT DOSE TO RESULT IN THE CUMULATIVE RADIATION DOSE DELIVERED). BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, IT'S SIEMENS' UNDERSTANDING IT IS MOST LIKELY THAT ONE OF THESE PATIENTS MAY HAVE RECEIVED A CUMULATIVE RADIATION DOSE OF 11%, WHICH IS ABOVE THE ACCEPTABLE INTERNATIONAL IEC* THRESHOLD OF 10% OF THE TOTAL DELIVERED RADIOTHERAPY PRESCRIPTION. IT'S OUR UNDERSTANDING THAT ALL OTHER REPORTED PATIENTS ARE WITHIN THE INTERNATIONAL IEC RANGE OF <10% FOR THE PRESCRIPTION DELIVERED. (NOTE, THE REPORTED INCIDENT OCCURRED IN FRANCE WHICH USES A 5% THRESHOLD; UNDER THIS THRESHOLD, THE OTHER 49 PATIENTS, WHOSE CUMULATIVE TOTAL DOSE REPORTEDLY RANGES BETWEEN >5% TO <10% WOULD EXCEED THE FRENCH STANDARD.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76140 MEVATRON M2/PRIMUS MID-ENERGY ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 01940035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other