BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPOE/EHR DEVICE

    MDR report key: 3806906 · Received May 8, 2014

    Report

    Report Number
    MW5036033
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 21, 2014
    Manufacturer
    PRO TOUCH/KINDRED
    Product Code
    NSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN ECHOCARDIOGRAM WAS ORDERED VIA CPOE TO EVALUATE A LOW CARDIAC OUTPUT STATE. THE UPDATE ON THE RESULTS SCREEN FOR IMAGING STATED THAT THE TEST WAS COMPLETED, AND THE TIME IT WAS COMPLETED. THERE IS AN OBLIGATE APPROXIMATE 24 HOURS DELAY FOR THE REPORT AND IMAGES TO APPEAR. AFTER 36 HOURS, THERE WAS NOT ANY RESULT AND AFTER 48 HOURS, A CALL WAS MADE TO THE ANCILLARY DEPARTMENT. THE IMAGING WAS NEVER DONE, EVEN THOUGH THE UPDATE STATED COMPLETE. THIS DELAY IN KNOWING CARDIAC FUNCTION STATUS WAS A CRITICAL ADVERSITY AND IMPEDIMENT TO THE CARE OF THIS PT WHO DIED A FEW DAYS LATER FROM AN INFECTION, THOUGH THIS DELAY WAS NOT THE CAUSE OF THE INFECTION. THE FAILURE OF ANCILLARY DEPARTMENTS TO GET ACCURATE ORDERS IS AN ONGOING PROBLEM WITH ALL CPOE SYSTEMS DUE TO INTERFACE AND INTEROPERABILITY ISSUES. THEY CAN NOT BE TRUSTED TO ENABLE TIMELY TESTING WITHOUT INTENSE VIGILANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279045 CPOE/EHR DEVICE CPOE/EHR NSX PRO TOUCH/KINDRED

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening