BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEVIEW

    MDR report key: 274705 · Received April 20, 2000

    Report

    Report Number
    2910081-2000-00002
    Event Type
    Injury
    Date Received
    April 20, 2000
    Date of Event
    March 17, 2000
    Report Date
    April 20, 2000
    Manufacturer
    SIEMENS MEDICAL SYSTEMS
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A PT TREATMENT PRESCRIPTION CALLED FOR FOUR CONFORMAL MULTILEAF COLLIMATOR FIELDS. A TREATMENT ERROR OCCURRED IN THAT THREE OF THE FOUR CONFORMAL FIELDS WERE TREATED WITH RECTANGULAR FIELDS FOR SEVERAL DAYS. ALTHOUGH AN INITIAL PORT VERIFICATION FILM WAS TAKEN AND DID INDICATE THE INCORRECT FIELD, THE FILM WAS NOT IMMEDIATELY READ AND TREATMENT WAS INITIATED. THESE TREATMENTS WERE DELIVERED USING THE SIEMENS "PRIMEVIEW" SOFTWARE PRODUCT IN CONJUNCTION WITH A SIEMENS "PRIMUS" MACHINE. THE FOLLOWING TRANSCRIPTS ARE THE RESULT OF THE ON-SITE (SIEMENS) INVESTIGATOR'S INTERPRETATION OF THE CUSTOMER'S DESCRIPTION COMBINED WITH THE INTERPRETATION OF THE DIGITAL MEVATRON INTERFACE PROTOCOL LOG FILE ENTRIES FOR THE SPECIFIC TIMES & DATES OF INTEREST. THE CONDITIONS THAT PRECEDED THIS PRIMEVIEW TREATMENT FIELD EVENT ARE DESCRIBED AS FOLLOWS: THE DOSIMETRIST HAD USED A CMS "FOCUS" TREATMENT PLANNING SYSTEM TO CREATE 4 CONFORMAL MLC SHAPED TREATMENT FIELDS, AND HAD LABELED THEM "01, 02, 03, 04". THESE FIELDS WERE THEN IMPORTED INTO THE LANTIS SYSTEM USING THE RADIOTHERAPY TREATMENT PLANNING LINK FEATURE. AFTER IMPORTING THESE FIELDS INTO LANTIS, THE DOSIMETRIST WISHED TO MODIFY SOME OF THE FIELDS. THEREFORE, DOSIMETRIST THEN CREATED AND IMPORTED A REPLACEMENT SET OF FOUR NEW CONFORMAL MLC SHAPED TREATMENT FIELDS LABELING THEM "1A, 2A, 3A, 4A". THE ORIGINAL FOUR TREATMENT FIELDS REMAINED IN LANTIS, AND WERE HIDDEN TO PREVENT INADVERTENTLY USING THEM. THE DESCRIPTION OF THE ACTUAL TREATMENT FIELD EVENT IS AS FOLLOWS: THE ATTENDING USED THE PRIMEVIEW PRODUCT TO OPEN THE PT RECORD FOR THE PT, ID# 00-0230. UPON DOING SO THERE WERE THREE SEQUENTIAL PRIMEVIEW ERROR MESSAGES DISPLAYED ON THE PROFESSIONAL COMPUTER MONITOR. THE TEXT DISPLAYED IN EACH OF THESE SEQUENTIAL ERRORS READS AS FOLLOWS: "ERROR:IN FIELD 2A:POST PANCREAS, NO MLC SHAPE HAS BEEN DEFINED FOR THIS FIELD, USING BLOCK MODE. ERROR:IN FIELD 3A:RT LAT PANCREAS, NO MLC SHAPE HAS BEEN DEFINED FOR THIS FIELD USING BLOCK MODE. ERROR:IN FIELD 4A:LT LAT PANCREAS, NO MLC SHAPE HAS BEEN DEFINED FOR THIS FIELD USING BLOCK MODE." AN "RTT" AT THE TREATSTATION SAW THE THREE ERROR MESSAGES, AND ACKNOWLEDGED EACH OF THEM IN SUCCESSION BY USING THE PROFESSIONAL COMPUTER MOUSE TO SELECT THE "OK" MESSAGE BUTTON. ONCE THE ERROR MESSAGES HAD FINISHED POSTING, THE "RTT" WAS ABLE TO CONTINUE WITH THE TASK OF DOWNLOADING & DELIVERING THAT SPECIFIC SET OF FOUR PT TREATMENT FIELDS. AT SOME POINT AFTER THE FOUR TREATMENT FIELDS ("1A, 2A, 3A, 4A") WERE DELIVERED, AN INDIVIDUAL RESPONSIBLE FOR REVIEWING THE DAILY TREATMENTS DETERMINED THAT THERE HAD BEEN AN ERROR WITH THAT PARTICULAR PT'S TREATMENT DELIVERY. AT SOME POINT AFTER THIS DISCOVERY, IT WAS DECIDED TO IMPORT A NEW SET OF TREATMENT FIELDS IN ORDER TO OBTAIN A CORRECTED SET OF FOUR DOWNLOADABLE CONFORMAL MLC SHAPED FIELDS. SINCE THE FIRST TREATMENT FIELD "1A" FROM THE PREVIOUS SET OF 4 HAD DOWNLOADED AS A CONFORMAL MLC SHAPED FIELD IT WAS DECIDED TO IMPORT ONLY THREE REPLACEMENT FIELDS, THE NEW FIELDS WERE LABELED "02A, 03A, 04A". THE THREE UNDESIRABLE FIELDS THAT WERE REPLACED REMAINED IN LANTIS, BUT WERE HIDDEN TO PREVENT INADVERTENTLY USING THEM. PT TREATMENTS HAVE SINCE CONTINUED AS DESIRED USING THE FINAL SET OF FOUR DOWNLOADABLE CONFORMAL MLC SHAPED FIELDS LABELED "1A, 02A, 03A, 04A". THE LOG FILE FOR THIS TREATMENT MACHINE CONFIRMS THE TIMES & DATES WHEN THE PT TREATMENTS WERE DELIVERED. THE LOG FILE ALSO SHOWS THAT ON TWO TREATMENT DATES THE FIRST TREATMENT FIELD "1A" WAS INTERPRETED BY PRIMEVIEW AS BEING A CONFORMAL FIELD, WHEREAS THE NEXT THREE FIELDS "2A, 3A, 4A" WERE INTERPRETED AS BEING RECTANGULAR FIELDS. A COPY OF THE LOG FILE, WHICH SHOWS THESE EVENTS, HAS BEEN MADE FOR THE FILE. THE LOG SHOWS THAT ON THE FIRST TREATMENT DATE OF 3/16/00, THERE WERE FOUR FIELDS THAT WERE DOWNLOADED AS CONFORMAL MLC SHAPES. THE FIELDS THEN CHANGED ON 3/17/2000 SO THAT PRIMEVIEW RECOGNIZED ONLY ONE OF THE FOUR FIELDS AS BEING AN MLC CONFORMAL SHAPE. THIS CONTINUED TO BE THE CASE DURING THE NEXT TREATMENT DAY ON 3/20/00. IN CONCLUSION, ANY FURTHER INFO AS TO THE STATUS OF THE PT AS A RESULT OF THE FIELD SHAPE TREATMENT ERROR COULD NOT BE OBTAINED FROM THE CUSTOMER BASED ON "PT PRIVACY" CONCERNS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other