BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE CARDIVASCULAR

    MDR report key: 3810401 · Received April 11, 2014

    Report

    Report Number
    2443168-2014-00001
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 31, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DIFFERENT PATHS TO THE SAME ISSUE, I.E., THE PT DEMOGRAPHICS IN THE EMR REPORT MAY NOT MATCH THE NAME ON THE PT'S FOLDER. HOWEVER, SINCE THE ISSUE PRESENT THEMSELVES IN A SIMILAR MANNER AND BECAUSE THEY APPEAR AFTER CONVERSION TO HL7 FORMAT AND EXPORT TO THE EMR, FMSU HAS DETERMINED THAT THEY ARE SIMILAR ENOUGH TO REPORT IN A SINGLE REPORT. 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 HL7 REPORT AND THE SUBSEQUENT EXPORTING OF THE HL7 FILE TO THE EMR. FURTHER, THE EMR REPORT IS NOT REFERED TO IN REAL TIME AS A PARTICULAR CARDIOVASCULAR PROCEDURE IS BEING PERFORMED. RATHER, THEY ARE VIEWED WHEN THE REFERRING PRACTITIONER WISHES TO REVIEW A PT'S PREVIOUS DATA. AS A CONSEQUENCE, FMSU BELIEVE 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 PT DEMOGRAPHICS IN A REPORT EXPORTED INTO THE EMR MAY NOT MATCH THE DEMOGRAPHICS SHOWN IN THE CORRESPONDING SYNAPSE CV CLINICAL REPORT. THUS, WHILE THE CLINICAL DATA IN THE CLINICAL REPORT IS CORRECT, THE PT'S DEMOGRAPHIC INFO, E.G., DATE OF BIRTH, DISPLAYED IN THE EMR REPORT MAY BE THAT OF ANOTHER PT. THE ISSUE PRESENTS ITSELF UNDER TWO SCENARIOS: MULTIPLE REPORTS ARE GENERATED IN SYNAPSE CV BY A SINGLE USER. HL7 REPORTS ARE GENERATED FOR EACH CV CLINICAL REPORT AND EXPORTED TO AN EMR. THE "SWITCH USER" FEATURE IN WINDOWS 7 IS ENABLED; THIS FEATURE IS THAT IT ALLOWS USERS TO OPEN A SESSION WHILE THE FIRST USER US STILL LOGGED ON. THE ADVANTAGE OF THIS FEATURE IS THAT IT ALLOWS USERS TO SWITCH BETWEEN USER ACCOUNTS PON A SINGLE WORKSTATION WITHOUT QUITTING APPLICATIONS AND LOGGING OUT. REPORTS ARE GENERATED AND FINALIZED IN SYNAPSE CV AND AN HL7 REPORT IS GENERATED WHICH INCLUDES AN EMBEDDED PDF FILE. IF A SINGLE USER PERFORMS THIS SEQUENCE FOR SEVERAL PTS, THE FIRST REPORT IN THE SEQUENCE IS CORRECT. HOWEVER, SUBSEQUENT HL7 REPORTS MAY CONTAIN EMBEDDED PDF FILES OF A DIFFERENT PT. THUS, THE PDF FILE FOR PT A MAY BE PLACED INTO PT B'S FOLDER. WHILE PT A'S DATA, INCLUDING IDENTIFIERS SUCH AS NAME, IS CORRECT FOR PT A, IT NEVERTHELESS IS EMBEDDED IN THE WRONG PT'S FILE. NO MEDICAL INTERVENTION WAS INDICATED BY THE REPORTING SITE. IT SHOULD BE NOTED THAT, IN GENERAL, A CLINICAL REPORT IS FORWARDED DIRECTLY FROM SYNAPSE CV TO THE REFERRING PHYSICIAN VIA FAX AND THAT EMR REPORT IS RETAINED PRIMARILY FOR HISTORICAL PURPOSES. IN BOTH CASES CITED, THE CLINICAL REPORT IN SYNAPSE CV REMAINS UNCHANGED AND IS CORRECT. 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. FURTHER THIS TOOL PROVIDED THE SITE WITH THE OPTION TO ANNOTATE THE UPDATES 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 PRACTITIONERS THAT THE FILE MAY HAVE 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
    221645 SYNAPSE CARDIVASCULAR PROGRAMMABLE DIAGNOSTIC DEVICE DQK FUJIFILM MEDICAL SYSTEM U.S.A., INC. V4.0.8

    Patients

    Seq Age Sex Outcome Treatment
    1