BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON CARDIOLOGY HEMO

    MDR report key: 1515311 · Received April 22, 2009

    Report

    Report Number
    9616760-2009-00001
    Event Type
    Other
    Date Received
    April 22, 2009
    Date of Event
    February 23, 2009
    Report Date
    March 25, 2009
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    PMA / PMN Number
    K050561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2009, MCKESSON (B)(4) RECEIVED A COPY OF A MEDWATCH USER FACILITY REPORT FILED WITH FDA ON MARCH 13, 2009 BY (B)(6) MEDICAL CENTER, (B)(6). (B)(4). MCKESSON IS SUBMITTING THE ENCLOSED MEDWATCH REPORT TO CLARIFY INFO SUBMITTED BY THE USER FACILITY IN MEDWATCH REPORT (B)(4) AND TO PROVIDE EVIDENCE SUPPORTING MCKESSON (B)(4) DECISION THAT THE REPORTED EVENT DOES NOT MEET THE CRITERIA FOR A MANDATORY MEDICAL DEVICE REPORTABLE EVENT UNDER 21 CFR 803. ON FEBRUARY 23, 2009 MCKESSON (B)(4) RECEIVED INFORMATION FROM (B)(6) MEDICAL CENTER INDICATING THAT THE INFORMATION SYSTEM MODULE OF HORIZON CARDIOLOGY HEMO FROZE FOR SIX MINUTES. DISPLAY OF UPDATED OPERATOR CHARTING OF SOME CATHETERIZATION PROCEDURE DATA FOR THE PATIENT DID NOT OCCUR DURING THIS TIME. HOWEVER, VALUES FOR ALL THE PHYSIOLOGICAL PARAMETERS MONITORED DURING THE PROCEDURE CONTINUED TO BE DISPLAYED IN REAL-TIME AND ALL DATA COLLECTED DURING THE PROCEDURE WAS STORED ON THE SYSTEM. MCKESSON'S ROOT CAUSE ANALYSIS OF THE EVENT DETERMINED THAT THE PROBLEM AFFECTED ONLY HORIZON CARDIOLOGY HEMO VERSION 11.0.0.4.236 WHEN CARDIAC OUTPUT MEASUREMENT PROCESS CANNOT OBTAIN STABILIZED TEMPERATURE AND CHARTING PROCESS OF VITALS SNAPSHOT (SAMPLE) ARE BEING PERFORMED SIMULTANEOUSLY. THE DISPLAY OF UPDATED GRAPHS OF SOME CATHETERIZATION PROCEDURE DATA WOULD RESUME WHEN A WATCHDOG MECHANISM EMBEDDED IN THE SOFTWARE DETECTS THE SCENARIO. MCKESSON'S ANALYSIS ALSO DETERMINED THAT FOR THE EVENT AND THE DISCOVERED PROBLEM, ALL THE PHYSIOLOGICAL PARAMETERS MONITORED DURING A PROCEDURE CONTINUED TO BE/WOULD CONTINUE TO BE DISPLAYED IN REAL-TIME AND ALL DATA COLLECTED DURING A PROCEDURE WAS STORED/WOULD BE STORED ON THE SYSTEM. THUS, THE LIKELIHOOD OF SERIOUS INJURY TO A PATIENT AS A RESULT OF THE PROBLEM IS EXTREMELY UNLIKELY AND AS A RESULT IT DID NOT/DOES NOT MEET THE CRITERIA FOR A MANDATORY MEDICAL DEVICE REPORTABLE EVENT. A SOFTWARE UPDATE WAS DEVELOPED TO ELIMINATE THE PROBLEM AND ON MARCH 11, 2009, IT WAS INSTALLED ON THE SITE'S SIX AFFECTED HORIZON CARDIOLOGY HEMO VERSION 11.0.0.4.236 SYSTEMS. MCKESSON ALSO VERIFIED THAT THE SOFTWARE UPDATE WAS IMPLEMENTED ON ADDITIONAL TWO SITES THAT UTILIZED HORIZON CARDIOLOGY HEMO VERSION 11.0.4.236.

    Description of Event or Problem · 1

    DURING A CARDIAC CATHETERIZATION PROCEDURE, THE INFORMATION SYSTEM MODULE OF THE HORIZON CARDIOLOGY HEMO SYSTEM COLLECTED BUT DIDN'T ALLOW CHARTING OF PRESSURES AND CARDIAC OUTPUT PARAMETERS FOR A PERIOD OF 6 MINUTES. REAL-TIME VALUES FOR ALL THE PHYSIOLOGICAL PARAMETERS MONITORED DURING THE PROCEDURE CONTINUED TO BE AVAILABLE DURING THE ENTIRE PROCEDURE AND ALL DATA COLLECTED DURING THE CASE WAS STORED ON THE SYSTEM. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON CARDIOLOGY HEMO HEMODYNAMIC SYSTEM DQK MCKESSON ISRAEL LTD. HCH 11.0

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR