BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 5736923 · Received June 20, 2016

    Report

    Report Number
    9616760-2016-00001
    Event Type
    Death
    Date Received
    June 20, 2016
    Date of Event
    April 20, 2016
    Report Date
    June 20, 2016
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    MWI
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE PATIENT'S CONDITION DETERIORATED, THE PROCEDURE HAD BEEN SIGNED, BUT THE MCKESSON CARDIOLOGY HEMO APPLICATION WAS STILL OPEN ON THE WORKSTATION. THE USER UN-SIGNED THE PROCEDURE AND ATTEMPTED TO INITIATE "VITALS CHARTING" FROM THE PROCEDURE NOTE TAB, IN ORDER TO AUTOMATICALLY MONITOR THE PATIENT'S BLOOD PRESSURE EVERY FEW MINUTES. A MESSAGE APPEARED INDICATING THAT THE "VITALS CHARTING" FUNCTION WAS DISABLED FOR THE PROCEDURE. AS A RESULT, THE USER INSTEAD COLLECTED AND RECORDED NIBP MEASUREMENTS MANUALLY EVERY FEW MINUTES USING THE MCKESSON CARDIOLOGY HEMO APPLICATION. BASED ON AN ANALYSIS OF THE APPLICATION LOG FILES, AND FURTHER DISCUSSION WITH THE REPORTING FACILITY, THERE IS NO INDICATION THAT THE MCKESSON CARDIOLOGY HEMO APPLICATION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THE REPORTING FACILITY ALLEGED THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP)COULDN'T BE MEASURED AUTOMATICALLY IN THE SYSTEM DURING AN EMERGENCY PROCEDURE. THE PATIENT UNDERWENT A ROUTINE HEART CATHETERIZATION PROCEDURE AT THE REPORTING FACILITY. FOLLOWING THE PROCEDURE, THE PATIENT WAS INITIALLY STABLE, AND PREPPED FOR REMOVAL FROM THE CATH LAB. THE USER CLOSED AND SIGNED THE PROCEDURE IN MCKESSON CARDIOLOGY HEMO. WHEN THE PATIENT'S CONDITION SUDDENLY DETERIORATED, THE USER RE-OPENED AND UN-SIGNED THE SAME PROCEDURE IN MCKESSON CARDIOLOGY HEMO. WHILE THE PATIENT WAS BEING RESUSCITATED, THE USER ATTEMPTED TO INITIATE "VITALS CHARTING" IN ORDER TO AUTOMATICALLY MONITOR THE PATIENT'S BLOOD PRESSURE EVERY FEW MINUTES. A MESSAGE APPEARED INDICATING AUTOMATIC NIBP MONITORING WAS DISABLED FOR THE PROCEDURE. USING AN ALTERNATE FUNCTION IN THE MC HEMO APPLICATION, THE USER PROCEEDED TO OBTAIN NIBP MEASUREMENTS MANUALLY EVERY FEW MINUTES. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389668 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO MWI MCKESSON ISRAEL LTD. 13.0 HF3

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death