BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON CARDIOLOGY HEMO

    MDR report key: 1655297 · Received April 1, 2010

    Report

    Report Number
    9616760-2010-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2010
    Manufacturer
    MCKESSON ISRAEL LTD
    Product Code
    DQK
    PMA / PMN Number
    K050561
    Removal / Correction Number
    A 21CFR806 RPT WILL BE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON EVALUATED THE AFFECTED SYSTEM, AND IDENTIFIED THE ROOT CAUSE OF THE EVENT AS THE CONFIGURATION TO GENERATE TECHNICAL SUPPORT LOG FILES IN A COMPONENT PHYSIOLOGICAL DATA COLLECTION UNIT - THE SCHILLER ARGUS PRO PB-1000 MONITOR UNIT. THERE WAS A CONFLICT WITHIN THE SCHILLER ARGUS PRO PB-1000 MONITOR UNIT, BETWEEN THE PROCESS OF GENERATING THE LOG FILES AND THE PROCESS OF ACQUIRING PT PHYSIOLOGICAL PARAMETERS. THIS CONFLICT LEAD TO A DELAY IN THE SENDING OF THE REAL TIME PHYSIOLOGICAL PARAMETERS TO THE REAL TIME MONITOR OF THE HORIZON CARDIOLOGY HEMO SYSTEM. THIS RESULTED IN A DELAY IN THE DISPLAY OF THE PARAMETERS IN REAL TIME ON THE HORIZON CARDIOLOGY HEMO REAL TIME MONITOR SCREEN AND ON THE PT RECORD. THE FUNCTION TO GENERATE LOG FILES WAS CONTAINED IN A SPECIFIC FIRMWARE VERSION INSTALLED ON THE SCHILLER ARGUS PRO PB-1000 MONITOR UNIT. THIS SPECIFIC FIRMWARE VERSION DID NOT MEET THE PERFORMANCE SPECIFICATION TO SENT THE PT'S PHYSIOLOGICAL PARAMETERS IN REAL TIME. A MCKESSON'S SUPPORT ENGINEER REMOVED THE SPECIFIC FIRMWARE VERSION ON THE SCHILLER ARGUS PRO PB-1000 MONITOR UNIT, AND REPLACED IT WITH A VERSION THAT DID NOT HAVE THE FUNCTIONALITY TO GENERATE LOG FILES. THE SUPPORT ENGINEER THEN TESTED THE SYSTEM AND VERIFIED THAT THE REPORTED ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, MCKESSON'S SUPPORT REP RECEIVED A SERVICE REPORT STATING THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, THE HORIZON CARDIOLOGY HEMO SYSTEM DISPLAYED A PT'S WAVEFORMS WITH A DELAY OF APPROXIMATELY 12 SECONDS, INSTEAD OF HAVING IT DISPLAYED AS THE PARAMETERS ARE BEING GATHERED (I.E. IN REAL TIME). DUE TO THE DELAY, THE MEDICAL STAFF HAD DIFFICULTY MEASURING THE PT'S HEART VALVE AREA. FURTHER INFO IS BEING COLLECTED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON CARDIOLOGY HEMO HEMODYNAMIC SYSTEM DQK MCKESSON ISRAEL LTD HCH12.1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR