BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 11594785 · Received March 31, 2021

    Report

    Report Number
    11594785
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 11, 2021
    Report Date
    March 12, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD NEW ORDER FOR PRECEDEX INFUSION. INFUSION STARTED 2032 AT LOWEST DOSE PER ORDER: 0.2MCG/KG/H RESULTING IN 4.98ML/H DOSE TO PATIENT. MEDICATION SCANNED THROUGH EPIC AND SENT TO PUMP. CONFIRMED DOSE ON PUMP. AT APPROXIMATELY 2225 PUMP ALARMED AIR IN LINE AND UPON CHECKING THE BOTTLE OF PRECEDEX IT WAS COMPLETELY EMPTY WITH AIR IN LINE DOWN TO ALARIS CHANNEL. MODULE PAUSED. MODULE SETTINGS WERE RECHECKED ON PUMP AND STATED DEXMEDETOMIDINE DRUG AMOUNT: 400MCG DILUENT VOLUME 100ML PATIENT WEIGHT (B)(6) TIME UNITS: HOUR DOSING UNITS MCG/KG/H UNITS: 4MCG/ML RATE: 4.98ML/HR VTBI: 80.6ML DOSE: 0.2 MCG/KG/MIN. PUMP MODULE SHUT OFF AND RESIDENT NOTIFIED. CHANNEL AND ASSOCIATED BRAIN TAKEN OUT OF ROOM, TICKET CREATED AND TO BE SENT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494476 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA