BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOUCH

    MDR report key: 2213261 · Received August 10, 2011

    Report

    Report Number
    MW5021725
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 10, 2011
    Manufacturer
    VENCOR
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WITH A MULTIPLE ORGAN FAILURE SYNDROME HAD AN ARRHYTHMIA CONSISTING OF WIDE COMPLEX TACHYCARDIA. AN ORDER TO NOT GIVE THE PT THE PREVIOUSLY ORDERED DIGOXIN DOSE UNTIL A SERUM LEVEL WAS VERIFIED WAS ENTERED USING CPOE. THE LEVEL RETURNED AT A SATISFACTORY RANGE. ON THE PROCEEDING DAY, THE SCREEN SHOWING RECENT ORDERS INDICATED THAT THE MEDICATION HAD BEEN DISCONTINUED. CLINICAL AND PHARMACOLOGICAL DECISIONS WERE MADE BASED ON THAT. IT WAS ERRONEOUS INFO. THE MEDICATION APPEARED TO HAVE BEEN DISCONTINUED, BUT IT WAS STILL BEING ADMINISTERED. WITH A MEDICATION OF NARROW THERAPEUTIC RATIO, THE SAFE ADMINISTRATION REQUIRES PRECISE DETAIL OF ADMINISTRATION AND SCHEDULE. THIS DETAIL INVOLVED THE CPOE SYSTEM'S FALSE LISTING OF A DISCONTINUATION OF A MEDICATION OF NARROW THERAPEUTIC RATIO PUTTING THE PT AT RISK FOR TOXICITY, VENTRICULAR TACHYCARDIA, AND DEATH. THE CLINICIAN WAS LED TO BELIEVE FROM THE ELECTRONIC RECORD THAT THE MEDICATION HAD BEEN DISCONTINUED, WHEN IT WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOUCH PROTOUCH CPOE ELECTRONIC MEDICAL RECORD NSX VENCOR

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| O