BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUENCER

    MDR report key: 960814 · Received December 7, 2007

    Report

    Report Number
    2950347-2007-00004
    Event Type
    Injury
    Date Received
    December 7, 2007
    Date of Event
    November 6, 2007
    Report Date
    November 19, 2007
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K981313
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WARNING SIGNALS THE USER TO REVIEW AND VERIFY THE TREATMENT, AND THEN MANUALLY RECORD THE TREATMENT VALUES IN SEQUENCER. THE USER RESUMED TREATMENT FOR FIELDS 3 AND 4 WITHOUT RETREATING FIELDS, 1, 1A, 1B, 1C, 2, 2A, 2B AND 2C WHICH INDICATES THAT THE USER REVIEWED THE TREATMENT RECORD BUT DID NOT MANUALLY RECORD THE FIELDS. THE USER SUBSEQUENTLY REVIEWED THE TREATMENT CHART, NOTED THAT THE FIELDS WERE NOT RECORDED, AND THEN RE-TREATED FIELDS 1, 1A, 1B, 1C, 2, 2A, 2B AND 2C IN 2007, RESULTING IN AN OVERDOSE OF 180CGY. USERS ARE TRAINED TO RECOGNIZE MESSAGE WARNINGS FOR USE WITH SEQUENCER. SOFTWARE INSTRUCTIONS FOR USE ARE AVAILABLE AND CLEARLY DEFINED FOR THE USER. THERE WAS NO SOFTWARE MALFUNCTION, AND THE MISTREATMENT WAS DUE TO USER ERROR. THE USER DID NOT REVIEW THE TREATMENT FIELDS THAT HAD BEEN DELIVERED AND DID NOT PERFORM A CHART REVIEW WHEN THE MESSAGE "ALL FIELDS NOT TREATED WARNING" APPEARED.

    Description of Event or Problem · 1

    IN 2007, A COMMUNICATION ERROR BETWEEN IMPAC'S SEQUENCER RECORD AND VERIFY SYSTEM AND VARIAN'S 4D TREATMENT PLANNING SYSTEM OCCURRED DURING TREATMENT OF A PATIENT. TREATMENT FIELDS FROM TWO RX SITES WERE GROUPED TOGETHER IN A TREATMENT CALENDAR SESSION. FROM RX SITE, L BREAST, FIELDS: 1, 1A, 1B, 1C, 2, 2A, 2B AND 2C. FROM RX SITE, SUPRACLAV, THE FIELDS: 3 AND 4. THESE FIELDS WERE SENT TO 4D FOR TREATMENT ON THE SAME DAY. FIELDS FROM SITE, L BREAST, WERE SELECTED FIRST TO TREAT. DURING THE TREATMENT, A MACHINE COMMUNICATIONS TIME OUT OCCURRED AND THE PLAN FOR SITE, L BREAST, WAS EXITED. THE THERAPIST THEN CHOSE TO SEND THE SITE, SUPRACLAV, TO 4D FOR TREATMENT BUT GOT THE SAME MACHINE COMMUNICATIONS TIME OUT ERROR. MOSAIQ WAS RESTARTED OR REBOOTED. AFTER THE MACHINE WAS RESTARTED OR REBOOTED, THE THERAPIST SELECTED THE TREATMENT CALENDAR SESSION FOR THE EVENT DATE, AGAIN. THIS TREATMENT CALENDAR SESSION STILL HAD THE FIELDS FROM BOTH RX SITES. THIS TIME THE THERAPIST SELECTED ONLY FIELDS 3 & 4 FROM RX SITE, SUPRACLAV, FOR TREATMENT. THE FIELDS WERE TREATED AND RECORDED. THE THERAPIST THEN EXITED THE SESSION AND THIS PROMPTED AN "ALL FIELDS NOT TREATED WARNING" MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENCER RECORD AND VERIFY SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC. 40003-001000-RO NA

    Patients

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