BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 6413215 · Received March 17, 2017

    Report

    Report Number
    6413215
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    October 24, 2016
    Report Date
    February 21, 2017
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: SINCE THE ADOPTION OF OUR EMR I CENTRA, THE NURSES WERE REPORTING THAT THE VOLUMES THEY HAD PROGRAMMED INTO THE CARE FUSION PUMPS WERE NOT POPULATING INTO I AWARE CORRECTLY. WE PLACED MANY TICKETS LOOKING FOR A RESOLUTION. AFTER CAREFUL ANALYSIS WITH (B)(4) , IT WAS DECIDED THAT MORE THAN LIKELY IT WAS THE PUMP THAT WAS MALFUNCTIONING. WE THEN HAD PUMPS PULLED AS IT OCCURRED. THE PUMPS DID NOT APPEAR TO BE MALFUNCTIONING EITHER. IT WAS DECIDED THAT IT WAS THE PULLING OF SMALL VOLUMES, I REPORTED THIS TO CORPORATE QUALITY ADDITIONAL INFORMATION: SITUATION: THE NICUS AT 2 INTERMOUNTAIN FACILITIES HAVE SUBMITTED REPORTS REGARDING INCORRECT DOCUMENTATION OF IV FLUIDS. THE 3 EVENTS SHOW AN OVER DOSING OF MEDICATIONS. CAREFUSION LOGS DEMONSTRATE THE CORRECT AMOUNT BEING INFUSED. ISSUE: THERE IS AN ERROR IN THE DOCUMENTATION SOFTWARE OF THE CAREFUSION IV PUMP. BACKGROUND: AFTER GOING LIVE ON NEW EMR, NICU REPORTED 2 INCIDENCES OF WHERE THE RECORD DOCUMENTED AN OVERDOSE OF MEDICATION BEING INFUSED. THE PUMPS WERE PULLED, THE LOGS PULLED FOR BOTH INSTRUMENTS AND SENT TO CAREFUSION FOR EVALUATION. AFTER MONTHS OF F/U, CAREFUSION ACKNOWLEDGED AN "ERROR" IN THE CAREFUSION SYSTEM. OUR STAFF CAN SEE THAT IT IS IN THE CAREFUSION DOCUMENTATION SOFTWARE BUT CAREFUSION HAS STOPPED SHORT OF ADMITTING THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196838 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1