BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUENCER

    MDR report key: 883333 · Received July 17, 2007

    Report

    Report Number
    2950347-2007-00001
    Event Type
    Injury
    Date Received
    July 17, 2007
    Date of Event
    March 9, 2007
    Report Date
    June 14, 2007
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    PMA / PMN Number
    K981313
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    IMPAC HAS DETERMINED THAT A PT WAS TREATED USING A RADIATION PRESCRIPTION THAT WAS INCORRECTLY ADMINISTERED RESULTING IN AN ADDITIONAL 600 CGY BEING DELIVERED TO THE PATIENT. THE PRESCRIPTION CALLED FOR A TOTAL OF 3600 CGY TO BE DELIVERED IN 12 FRACTIONS (FX) OF 300 CGY AND INSTEAD A TOTAL 14 FRACTIONS TOTALING 4200 CGY WAS ADMINISTERED. THE HEALTH CARE PROFESSIONAL CREATED A FIELD FOR TREATMENT USING SEQUENCER PRIOR TO SETTING UP A TREATMENT CALENDAR AND THEN TREATED THE PT DESPITE MULTIPLE WARNING MESSAGES STATING "INVALID POSITION FOR COUCH" AND "FIELD NOT ASSOCIATED WITH RX SITE" WHICH THE USER CHOSE TO OVERRIDE TO CONTINUE TREATMENT. BASED ON THE FACT THAT THE USER WAS RECEIVING THIS MESSAGE, MEANT THAT THE FIELD 1 HAD NOT BEEN ASSOCIATED TO THE C7-T5 RX. SUBSEQUENTLY, A TREATMENT PRESCRIPTION WAS WRITTEN AND APPROVED FOR A TOTAL CUMULATIVE DOSE OF 3600 CGY TO BE DELIVERED IN 12 FX'S OF 300 CGY. AFTER THE INITIAL (2) TREATMENTS WERE DELIVERED THE HEALTH CARE PROFESSIONAL DECIDED TO CHANGE THE PRESCRIBED MU FROM 334 TO 336, SO FIELD 1A WAS CREATED BY COPYING FIELD 1 AND CHANGING THE MU. AFTER FIELD 1 WAS ASSOCIATED TO RX SITE C7-T5, THE HEALTH CARE PROFESSIONAL UTILIZED THIS RX SITE TO CREATE A TREATMENT CALENDAR. BASED ON THE FACT THAT FIELD 1 HAD BEEN GIVEN THE STATUS OF INACTIVE/HIDDEN AND NOT ASSOCIATED WITH RX SITE C7-T5, THE TREATMENT CALENDAR DID NOT TAKE INTO ACCOUNT THE 600 CGY THAT THE PT HAD ALREADY RECEIVED AND SCHEDULED (12) FRACTIONS. ALTHOUGH FILED 1 WAS INACTIVELY/HIDDEN, THE TREATMENT THAT WAS PREVIOUSLY DELIVERED TO THIS FIELD WAS VISIBLE TO THE HEALTH CARE PROFESSIONAL FROM THE PATIENTS TREATMENT CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENCER RECORD AND VERIFY SYSTEM KPQ IMPAC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other RADIATION THERAPY TREATMENT SYSTEM (MANY DEVICES)