BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE CARDIOVASCULAR

    MDR report key: 3810400 · Received April 11, 2014

    Report

    Report Number
    2443168-2014-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    November 8, 2013
    Report Date
    April 8, 2014
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    DQK
    PMA / PMN Number
    K023112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE REPORTED IN THIS DOCUMENT AFFECTS EMR REPORTS, WHERE THE EMR IS INTENDED TO BE UTILIZED AS A HISTORICAL DATABASE. AS STATED, CLINICAL REPORTS ARE GENERALLY DISTRIBUTED TO REFERRING PHYSICIANS DIRECTLY FROM THE SYNAPSE CARDIOVASCULAR DATABASE, WHICH ARE UNAFFECTED BY THE CONVERSION TO AN HL7 REPORT AND THE SUBSEQUENT EXPORTING OF THE HL7 FILE TO THE EMR. IN ADDITION, THE EMR REPORT IS NOT REFERRED TO IN REAL TIME AS A PARTICULAR CARDIOVASCULAR PROCEDURE IS BEING PERFORMED. RATHER, IT IS VIEWED WHEN THE REFERRING PRACTITIONER WISHES TO REVIEW A PT'S PREVIOUS DATA. AS A CONSEQUENCE, FMSU BELIEVES THE RISK TO PT HEALTH AND SAFETY IS LOW.

    Description of Event or Problem · 1

    FUJIFILM MEDICAL SYSTEMS U.S.A.'S (FMSU) SYNAPSE CARDIOVASCULAR (CV) PRODUCT HAS A FUNCTIONALITY THAT EXPORTS CLINICAL REPORTS IN SYNAPSE CV INTO AN HL7 MESSAGE, WHICH IS THEN SENT TO THE ELECTRONIC MEDICAL RECORDS (EMR) APPLICATION FOR ARCHIVAL PURPOSES. IT HAS BEEN REPORTED THAT UNDER CERTAIN CIRCUMSTANCES, THE REPORT IN THE EMR MAY NOT CORRECTLY REFLECT THE CORRESPONDING CLINICAL REPORT IN SYNAPSE CV. IN ALL CASES, THE CLINICAL REPORT REMAINS ACCURATE WHEN RETRIEVED DIRECTLY FROM THE SYNAPSE CV APPLICATION. WHEN MULTIPLE REPORTS ARE GENERATED BY A SINGLE USER IN A SINGLE SESSION AND EXPORTED VIA HL7 TO AN EMR ON A CLIENT CONFIGURED TO EXPORT HL7 ,CALCULATED VALUES DISPLAYED IN THE "MEASUREMENT" GRID OR THE WALL MOTION SCORING DATA IN THE EMR REPORT COULD BE INCONSISTENT WITH WHAT IS STORED IN THE SYNAPSE CV SYSTEM. HOWEVER, THE COMMENTS DISPLAYED IN THE EMR "FINDINGS" SECTION ARE ACCURATE AND CONSISTENT WITH THE SYNAPSE CV REPORT. IN GENERAL, A CLINICAL REPORT IS FORWARDED DIRECTLY FROM SYNAPSE CV TO THE REFERRING PHYSICIAN VIA FAX, WHEREAS THE EMR REPORT IS RETAINED PRIMARILY FOR HISTORICAL PURPOSES. FURTHER, REFERRING PHYSICIANS TYPICALLY REVIEW THE COMMENTS IN THE EMR REPORT AND NOT THE ACTUAL VALUES OBTAINED. THE ORIGINAL CLINICAL REPORT STORED IN SYNAPSE CV REMAINS UNCHANGED AND IT AVAILABLE FOR REVIEW, IF NECESSARY. USERS WERE CONTACTED AND ADVISED TO DISCONTINUE USING HL7 REPORTS PENDING FMSU DETERMINATION OF ROOT CAUSE. DATA OBTAINED FROM THE REPORTING SITE WERE REVIEWED AND THE ISSUE WAS REPLICATED AT THE MANUFACTURER'S SITE. FMSU HAS DEVELOPED A TOOL THAT OBTAINS CORRECT DATA FROM THE SYNAPSE CV DATABASE AND CREATES A CORRECTED HL7 REPORT. FMSU BELIEVES THIS TOOL SHOULD BE IMPLEMENTED AT ALL SITES THAT WERE AT ONE TIME ON VERSION 4.0.8 EVEN IF THEY HAVE UPDATED TO A MORE RECENT VERSION, AS THE EMR FILES GENERATED DURING THE TIME THE SITES WERE ON VERSION 4.0.8 MAY BE COMPROMISED. IN ADDITION, THIS TOOL PROVIDES THE SITE WITH THE OPTION TO ANNOTATE THE UPDATED REPORT WITH A COMMENT INDICATING THAT THE EMR REPORT HAS BEEN OVERWRITTEN. AS THE EMR APPLICATION IN MANY CASES IS UTILIZED AS A HISTORICAL ARCHIVE, FMSU BELIEVES SUCH A COMMENT IS NECESSARY TO ALERT THE REFERRING PRACTITIONER THAT THE FILE HAS BEEN MODIFIED. TO DATE, FMSU HAS RECEIVED NO REPORTS OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENTS DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221678 SYNAPSE CARDIOVASCULAR PROGRAMMABLE DIAGNOSTIC DEVICE DQK FUJIFILM MEDICAL SYSTEM U.S.A., INC. V4.0.8

    Patients

    Seq Age Sex Outcome Treatment
    1