BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPOE DEVICE

    MDR report key: 3339297 · Received September 4, 2013

    Report

    Report Number
    MW5031738
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    July 22, 2013
    Report Date
    September 3, 2013
    Manufacturer
    PRO TOUCH/KINDRED
    Product Code
    OUG
    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 PT WAS RECOVERING FROM SEPSIS, ACUTE KIDNEY, RESPIRATORY, AND HEART FAILURE. SUBTLE, BUT SUDDEN CLINICAL REGRESSION OCCURRED WITHOUT THE TRADITIONAL SIGNS OF SEPSIS OR GENITOURINARY INFECTION. URINE AND BLOOD CULTURES WERE ORDERED. THE CPOE OF THE EHR COMPUTER HAD CLINICAL DECISION SUPPORT (CDS). THE CDS DEVICE AUTOMATICALLY DISCONTINUED THE URINE CULTURE AND ORDERED A URINALYSIS ON THE DOCTORS' TWO ATTEMPTS TO ORDER THE DISEASE CRITICAL DIAGNOSTIC TESTS. APPROX 4 DAYS PASSED AND THERE STILL WAS NOT A URINE CULTURE, WHILE THE PT SLIPPED BACK IN TO KIDNEY FAILURE, RESPIRATORY FAILURE, AND PULMONARY EDEMA AND WAS PLACED BACK ON THE VENTILATOR. FINALLY, SEVERAL MORE DAYS LATER, A URINE CULTURE WAS DONE SHOWING >100,000 GRAM NEGATIVE RODS, THAT THEN GREW OUT OF THE BLOOD CULTURE. THE DELAY IN DIAGNOSIS WAS DIRECTLY A RESULT OF THE CDS USURPING THE ROLE OF DOCTOR, COUNTERMANDING TESTS. THIS CDS DEVICE DOES NOT HAVE ANY FUNCTIONAL OVER RIDE TO GET THE URINE CULTURE DONE. DEATH FROM THE DELAY IN DIAGNOSING AND TREATING SEPSIS WAS NARROWLY AVOIDED. THE CDS DEVICE IS DEFECTIVE IN SO FAR AS IT DOES NOT PERMIT AN OVER RIDE, EVEN IF IN THE BEST JUDGEMENT OF THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437439 CPOE DEVICE CPOE DEVICE OUG PRO TOUCH/KINDRED

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| O| R