BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEVIEW

    MDR report key: 221710 · Received May 4, 1999

    Report

    Report Number
    2910081-1999-00002
    Event Type
    Injury
    Date Received
    May 4, 1999
    Date of Event
    April 9, 1999
    Report Date
    May 3, 1999
    Manufacturer
    SIEMENS MEDICAL SYSTEM / ONCOLOGY CARE SYSTEMS
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS RECEIVING A SERIES OF RADIATION THERAPY TREATMENTS USING THE 6 MV PHOTON MODE PRODUCED BY A MEDICAL LINEAR ACCELERATOR SYSTEM. THE FINAL TREATMENT WAS PLANNED TO BE ON APRIL 7, 1999 WHEN 1800 MU WOULD HAVE BEEN DELIVERED. HOWEVER, THE USER INADVERTENTLY CONTINUED TO ADMINISTER 180 MU TREATMENTS FOR AN ADD'L 5 DAYS, RESULTING IN A TOTAL DOSE 2700 MU OR 900 MU GREATER THAN PLANNED. NO MEDICAL INTERVENTION INDICATED AS A RESULT OF THE OVERDOSE. THE USER COMPLAINTED THAT THE SYSTEM DID NOT INDICATE WHEN THE PLANNED NUMBER OF FRACTIONS OR THE PLANNED TOTAL DOSE HAD BEEN DELIVERED. THE SYSTEM VERSION EMPLOYED AT THIS FACILITY VERIFIES AND RECORDS DAILY TREATMENT PARAMETERS AND ACCUMULATES TOTAL DELIVERED DOSE, BUT DOES NOT FLAG THE OPERATOR WHEN ANY PARTICULAR VALUE HAS BEEN REACHED OTHER THAN BY THE USER OBSERVING THE PT RECORD. THE FOLLOWING STATEMENT APPEARS ON PAGE 21 OF THE PRIMEVIEW USER'S MANUAL: "PRIMEVIEW DOES NOT DISPLAY AN OPERATOR MESSAGE IF AN ATTEMPT IS MADE TO DOWNLOAD THE PT'S TREATMENT FIELDS WHEN PRESCRIBED NUMBER OF FRACTIONS HAS BEEN ACHIEVED". NO EQUIPMENT MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEVIEW RADIATION THERAPY IZO SIEMENS MEDICAL SYSTEM / ONCOLOGY CARE SYSTEMS PRIMEVIEW *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other