BEUDAMED
    FDA Adverse Event Summary report: N

    MERGE CADSTREAM

    MDR report key: 6111857 · Received November 17, 2016

    Report

    Report Number
    2183926-2016-00798
    Date Received
    November 17, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K092954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE, PER INFORMATION OBTAINED BY MERGE HEALTHCARE, INDICATES THAT THERE WAS A USER ERROR IN ADJUSTING THE NETWORK INTERFACE CARD (NIC) SPEED WHICH WAS NOT CONFIGURED AT OPTIMAL CAPACITY FOR THIS SITE'S STUDY SIZE. THE SYSTEM IS CUSTOMER OWNED VMWARE RUNNING CADSTREAM SOFTWARE. WHILE THE MERGE HEALTHCARE IMPLEMENTATION TEAM INITIALLY CONFIGURED THE NIC TRANSFER SPEED TO ENSURE THE MINIMUM PERFORMANCE SPECIFICATIONS WERE MET, IT WAS UP THE CUSTOMER TO TEST THE SYSTEM UPON DEGRADATION, AS DESCRIBED IN THE MERGE VIRTUALIZATION CUSTOMER GUIDE. THE CUSTOMER DID NOT CONTACT SUPPORT FOR ASSISTANCE PRIOR TO THIS OCCURRENCE TO PREVENT ON-GOING SLOW TRANSFER SPEEDS. ADDITIONALLY, A REVIEW BY CLINICAL SUPPORT SUGGESTS THE SURELOC IMAGE SIZE IS LARGER THAN EXPECTED FOR A BREAST BIOPSY STUDY. ISSUE APPEARS TO USER ERROR RELATED DUE TO THE HIGH NUMBER OF IMAGES AND THE LACK OF CONFIGURATION ADJUSTMENTS TO THE SYSTEM FOR THIS LARGER STUDY.

    Description of Event or Problem · 1

    CADSTREAM IS INTENDED TO BE USED IN THE VISUALIZATION, ANALYSIS, AND REPORTING OF MAGNETIC RESONANCE IMAGING (MRI) STUDIES. CADSTREAM SUPPORTS EVALUATION OF DYNAMIC MR DATA ACQUIRED DURING CONTRAST ADMINISTRATION. CADSTREAM PERFORMS OTHER USER SELECTED PROCESSING FUNCTIONS (SUCH AS IMAGE REGISTRATION, SUBTRACTIONS, MEASUREMENTS, 3D RENDERINGS, AND REFORMATS). CADSTREAM ALSO INCLUDES USER-CONFIGURABLE FEATURES FOR REPORTING ON FINDINGS IN BREAST OR GENERAL MRI STUDIES. ADDITIONALLY, CADSTREAM ASSISTS USERS IN PLANNING MRI GUIDED INTERVENTIONAL PROCEDURES. WHEN INTERPRETED BY A SKILLED PHYSICIAN, THIS DEVICE PROVIDES INFORMATION THAT MAY BE USED FOR SCREENING, DIAGNOSIS, AND INTERVENTIONAL PLANNING. PATIENT MANAGEMENT DECISIONS SHOULD NOT BE MADE BASED SOLELY ON THE RESULTS OF CADSTREAM. CADSTREAM MAY ALSO BE USED AS AN IMAGE VIEWER OF MULTI-MODALITY, DIGITAL IMAGES, INCLUDING ULTRASOUND AND MAMMOGRAPHY. CADSTREAM IS NOT INTENDED FOR PRIMARY INTERPRETATION OF DIGITAL MAMMOGRAPHY IMAGES. ON (B)(6) 2016 A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT IMAGES WERE SLOW TO LOAD DURING A BIOPSY PROCEDURE. THE CUSTOMER REPORTED COMPLETING THE BIOPSY BY ESTIMATING THE TARGET LOCATION OF THE BIOPSY BASED ON LANDMARKS AND NOT VISUAL ENHANCEMENT ON IMAGES. ESTIMATING TARGETS HAS THE POTENTIAL TO LEAD TO AN INCORRECT FOLLOW UP WHICH MAY LEAD TO A DELAY IN DIAGNOSIS AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762215 MERGE CADSTREAM IMAGING PROCESSING SYSTEM LLZ MERGE HEALTHCARE MERGE CADSTREAM V6.1.0.1010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other