BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANTIS COMMANDER

    MDR report key: 2395316 · Received December 22, 2011

    Report

    Report Number
    2910081-2011-00068
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    November 25, 2011
    Report Date
    November 25, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    OIS C1. I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS NOT RETURNED PARTICULAR DETAILS ABOUT THE PT REPORTED TO HAVE BEEN INVOLVED. THE MANUFACTURER'S PRELIMINARY INVESTIGATION BASED ON A REVIEW OF THE SITE'S SYSTEM LOG FILES AND CLARIFICATIONS FROM THE SITE PERSONNEL, INDICATE THE SYSTEM PERFORMED AS SPECIFIED AND THE INCIDENT IS LIKELY ATTRIBUTABLE TO USER ERROR; HOWEVER, ADDITIONAL MANUFACTURER REVIEW AND INVESTIGATION IS UNDERWAY. WE BECAME AWARE OF THIS RECENT INFO ON (B)(4) 2011.

    Description of Event or Problem · 1

    SIEMENS RECEIVED NOTIFICATION ON 04/08/2011 VIA E-MAIL FROM THE ACTING RADIATION THERAPY SERVICE MANAGER OF THE RADIATION THERAPY DEPARTMENT, WITH THE FOLLOWING REQUEST AND PARTICULARS: "CAN YOU INVESTIGATE THE PROBLEM OUTLINED BELOW AS AN URGENT PRIORITY? A TREATMENT FIELD IS OPENED IN LANTIS FOR ASSESSMENT OR AMENDMENT. IT IS THEN RE-APPROVED BUT NOT CLOSED. FURTHER CHANGES ARE THEN MADE TO THE FIELD AND IT IS THEN CLOSED. THE FIELD REMAINS APPROVED WITH THE FURTHER CHANGES. THEREFORE THERE IS A SERIOUS RISK OF MAKING AMENDMENTS TO A FIELD AND NOT BEING AWARE OF IT." THE SUMMARY OF POTENTIAL COMPLAINT ENTRY INDICATED "YES" TO "POTENTIAL COMPLAINT RELATIVE TO SAFETY" AND "UNKNOWN" TO BOTH "WAS THE DEVICE BEING USED TO TREAT OR DIAGNOSE PT DURING EVENT?" AND "WAS ANYONE INJURED (EVEN SLIGHTLY)?" THE MATTER WAS REFERRED TO THE THIRD-PARTY SOFTWARE PROVIDER FOR EVAL. IT WAS DETERMINED THE SYSTEM WORKED AS SPECIFIED AND THIS ASSESSMENT WAS PROVIDED TO THE COMPLAINANT SITE DURING A REGULAR SERVICE MEETING. A NEW COMPLAINT FILE WAS OPENED WHEN THE SITE CLARIFIED ON 11/25/2011 "THAT THERE WAS AN ACTUAL INCIDENT WHERE A PT WAS TREATED WITH THE WRONG FIELD SIZE POSSIBLE DUE TO THE ISSUE OUTLINED IN THE ORIGINAL COMPLAINT." THE SITE FURNISHED AN INCIDENT REPORT WHICH INDICATED "DIAGNOSIS CA PROSTATE; PRESCRIPTION AND FRACTIONATION 37# 74GY; DATE AND TIME (B)(6) 2011 3.30 PM; NO. FIELDS INVOLVED 1; NO. FRACTIONS INVOLVED 11; RADICAL TREATMENT; ERROR TYPE: DOSE/TUMOUR SITE" AND CONTAINED ADDITIONAL DETAILS ABOUT THE SITE'S INTERNAL ASSESSMENT. THE REPORT RECEIVED ON (B)(4) 2011 INDICATED A PT WAS INJURED, WITH EXTENT OF INJURIES "POSSIBLE RADIATION DAMAGE". INCIDENT REPORTED TO IRISH MEDICINE BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANTIS COMMANDER ONCOLOGY INFORMATION SYSTEM IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1