BEUDAMED
    FDA Adverse Event Other Summary report: N

    CADSTREAM

    MDR report key: 1698946 · Received May 22, 2010

    Report

    Report Number
    3003982333-2010-00002
    Event Type
    Other
    Date Received
    May 22, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 21, 2010
    Manufacturer
    MERGE CAD INC
    Product Code
    LLZ
    PMA / PMN Number
    K081556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBURBAN IMAGING "(B)(6) FACILITY" HAD BEEN USING CADSTREAM 4.X FOR BREAST MRI REPORTING FOR APPROX 5 YEARS. THE "(B)(6) FACILITY" WAS UPGRADED TO CADSTREAM 5.0 IN (B)(6) 2009 AND THE "(B)(6) FACILITY" JUST STARTED USING CADSTREAM IN (B)(6) 2009. IN (B)(6) 2009, BOTH THE (B)(6) FACILITIES CONSOLIDATED THEIR CADSTREAM SYSTEMS TO ONE CADSTREAM 5.0 ENTERPRISE SYSTEM (SERIAL (B)(4)). ALL CONFIGURATIONS FROM THE OTHER SERVERS WERE TRANSFERRED TO THIS CONSOLIDATED ENTERPRISE SERVER. THE (B)(6) FACILITY HAS BEEN VERY HAPPY WITH CADSTREAM ON THIS SERVER BUT THE (B)(6) FACILITY REPORTED IN (B)(6) 2009, THAT THE STUDIES WERE NOT PROCESSING HOW THEY USED TO ON THEIR PRIOR CADSTREAM 4.X SYSTEM. PRODUCT SUPPORT UPDATED THE PROCESSING SETTINGS TO TRY TO MEET THE RADIOLOGIST REQUEST. HOWEVER, THE RADIOLOGIST CALLED AGAIN IN (B)(6) 2009 AND (B)(6) 2010 REPORTING THE PROCESSING WASN'T AS EXPECTED AND EACH TIME THE CONFIGURATION WAS MODIFIED BY SUPPORT TO TRY TO MEET THE RADIOLOGIST REQUEST. IN (B)(6) 2010, THE RADIOLOGIST AND TECH WERE TRAINED ON HOW TO SET THEIR OWN STUDY PREFERENCES AND IN THE PROCESS THEY REALIZED THAT THEY HAD THEIR PEAK SERIES SET INCORRECTLY ON THE SECOND POST WHEN IT SHOULD BE SET ON THE FIRST POST. AFTER CORRECTING THE PEAK SERIES TO BE SET TO THE FIRST POST THE PROCESSING WAS AS EXPECTED BY THE RADIOLOGIST. THE SITE DETERMINED IT NECESSARY TO RE-PROCESS AND REVIEW ALL CASES PROCESSED WITH THE IMPROPER SETTINGS. (B)(4). ALL THREE OF THESE INCIDENTS ARE BEING REPORTED TO FDA IN SEPARATE MDR REPORTS.

    Description of Event or Problem · 1

    SOMETIME BETWEEN (B)(6) 2009 AND (B)(6) 2010, A PT UNDERWENT BREAST MRI SCREENING WITH IMAGE REVIEW PERFORMED IN CADSTREAM. THE IMAGING CENTERS CADSTREAM PROCESSING SETTINGS WERE NOT SETUP TO USE THE CORRECT POST AS PEAK IN THE DYNAMIC CONTRAST ENHANCED IMAGING SERIES. THE RADIOLOGIST WAS IMPROPERLY RELYING ON THE CADSTREAM OVERLAY TO DETERMINE REGIONS OF INTEREST (OFF-LABEL USE OF DEVICE). IN (B)(6) 2010, IT WAS REALIZED THAT THE PROCESSING SETTINGS WERE NOT APPROPRIATELY SET. THE SETTINGS WERE CORRECTED AND THE STUDY RE-PROCESSED. UPON REPROCESSING IT WAS DISCOVERED THAT THE PT HAD A LESION THAT WARRANTED A FOLLOW-UP BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADSTREAM LLZ MERGE CAD INC VERSION 5.0.7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention