BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRONIC MEDICAL RECORD

    MDR report key: 5690723 · Received May 25, 2016

    Report

    Report Number
    MW5062551
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 25, 2016
    Manufacturer
    EPIC
    Product Code
    NSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EHR MDDS COMPONENT FAILS TO PROVIDE ADEQUATE NOTICE THAT NEW LAB RESULTS HAVE BEEN DEPOSITED; AND MORE DANGEROUS, THERE IS ZERO NOTICE THAT THE SILENTLY DEPOSITED RESULTS HAVE LIFE THREATENING IMPLICATIONS. IN THIS CASE OF ATRIAL FIBRILLATION BEING TREATED WITH HEPARIN AND BEING CONVERTED TO COUMADIN (RECEIVING BOTH DRUGS), THE HEMOGLOBIN WAS 7.0 G/DL ON A 6 AM BLOOD DRAW. THE RESULT WAS IN THE SILO OF THE EHR, BUT NO ONE SAW IT BECAUSE THEY ALL ROUNDED EARLIER. IT WAS MORE THAN 12 HOURS LATER THAT IT WAS SEEN BY A HEALTH CARE PROFESSIONAL, DURING WHICH TIME FULL HEPARIN INFUSION CONTINUED. THE HEPARIN WAS STOPPED AT THE TIME THE RESULTS WERE SEEN BUT THE COUMADIN HAD ALREADY BEEN ADMINISTERED. THE NEXT MORNING, THE HEMOGLOBIN WAS LESS THAN 6 G/DL, THE PATIENT WAS BLEEDING FROM THE GI TRACT, AND THERE WAS INCIPIENT SHOCK REQUIRING ICU TRANSFER. THE DEVICE WAS DEFECTIVE IN THAT IT FAILED TO ALERT OF NEW RESULTS, WHICH RESULTED IN DELAY OF APPROPRIATE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335287 ELECTRONIC MEDICAL RECORD EHR/MDDS NSX EPIC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O| R