BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EHR

    MDR report key: 5476570 · Received March 1, 2016

    Report

    Report Number
    MW5060686
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    February 28, 2016
    Report Date
    March 1, 2016
    Manufacturer
    EPIC
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    THE CLINICAL DECISION SUPPORT DEVICE MITIGATING DRUG THERAPY FOR ALL PTS HAS POORLY USABLE FUNCTIONALITY SUCH THAT IT PRESSURES THE USER AND DEFAULTS TO HEPARIN THERAPY FOR PROTECTION FROM THROMBOSIS, BUT FAILS TO CONSIDER THE FREQUENT SITUATIONS WHEN THE PT IS ALREADY ON AN ANTICOAGULANT SUCH AS WARFARIN OR NOACS. IT REQUIRES A SIGNIFICANT AMOUNT OF CLINICIAN TIME TO CLICK THE WAY OUT OF THE MORASS OF THE FLAWED DECISION TREE TO CANCEL HEPARIN. IT IS SUFFICIENTLY ONEROUS THAT IT IS MUCH EASIER TO SIMPLY ALLOW THE PT TO REMAIN OVER ANTICOAGULATED, AS WAS THE CASE IN THIS PT. THIS PUTS MOST PTS AT HIGHER RISK OF BLEEDING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127172 EHR CLINICAL DECISION SUPPORT MMH EPIC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| O