BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMART PUMP

    MDR report key: 3302089 · Received August 13, 2013

    Report

    Report Number
    3302089
    Event Type
    Malfunction
    Date Received
    August 13, 2013
    Date of Event
    May 9, 2013
    Report Date
    August 13, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT ARRIVED FROM THE OR WITH ANESTHESIA TEAM AND CARDIAC FELLOW. THE PATIENT'S WEIGHT WAS (B)(6) KGS. THE PATIENT AWAKENED SHORTLY AFTER ARRIVAL, AND WAS AGITATED AND RESTLESS. AFTER REVIEW OF THE PROPOFOL DOSE ON THE ALARIS PUMP, THE WEIGHT WAS FOUND TO BE SET AT (B)(6) KGS NOT (B)(6) KGS. THE PATIENT WAS NOT RECEIVING ACCURATE WEIGHT BASED DOSE. THE PUMP WAS REPROGRAMMED TO ACCURATE WEIGHT AND SET AT 2 MG/KG/HOUR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387748 ALARIS SMART PUMP PUMP, INFUSION FRN CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR