BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON CARDIOLOGY HEMO

    MDR report key: 2410764 · Received January 9, 2012

    Report

    Report Number
    2410764
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    December 29, 2011
    Report Date
    January 9, 2012
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE MCKESSON HEMODYNAMIC APPLICATION EXPERIENCED ISSUES THAT PREVENTED THE USE OF THE SYSTEMS. MAIN THREE LABS INOPERABLE NECESSITATED DIVERTING POTENTIAL EMERGENCIES (ST SEGMENT ELEVATION MYOCARDIAL INFARCTION - STEMI) TO ANOTHER FACILITY THEREBY POTENTIALLY DELAYING CARE. FORTUNATELY, NO PATIENTS HAD TO BE DIVERTED DURING THE 3 HOURS SOFTWARE WAS INOPERABLE. THIS HOSPITAL IS A LEVEL 1 TRAUMA AND CARDIAC FACILITY.======================MANUFACTURER RESPONSE FOR HORIZON CARDIOLOGY HEMO, IMAGING APP & HEMO APP, HORIZON CARDIOLOGY HEMO, IMAGING APP & HEMO APP (PER SITE REPORTER).======================MCKESSON PERFORMING ROOT CAUSE ANALYSIS OF EACH HEMO STATION. LAB 1 HAD A CORRUPT USER PROFILE THAT PREVENTED THE NORMAL ACCOUNT FROM LOGGING IN. LABS 2&3 HAD CORRUPT SQL INSTANCES ON THEIR LOCAL DATABASES. FINAL DETERMINATION OF WHAT CAUSED BOTH CORRUPTIONS IS NOT COMPLETE, BUT IT WAS DETERMINED THAT THE SYSTEMS HAD BEEN "HARD BOOTED" (PRESSING POWER BUTTON TO RESTART) MANY TIMES. THIS IS A KNOWN WAY TO CAUSE SQL CORRUPTIONS. PREVENTATIVE MEASURES ARE TO CONFIGURE ONE PC TO BE A HOT SPARE. MCKESSON COMING ON SITE TO PHYSICALLY REBUILD TO A BASELINE "PRISTINE" BUILD. THIS WILL REMOVE ANY RESIDUAL SETTINGS FROM THE DEVICES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *