BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS

    MDR report key: 11715715 · Received April 23, 2021

    Report

    Report Number
    11715715
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    February 22, 2021
    Report Date
    February 26, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A LINEN CHANGE THE PATIENT STARTED TO BECOME ACUTELY BRADYCARDIC AND HYPOTENSIVE. A DOPAMINE DRIP WAS ALREADY PRIMED AND PREPROGRAMED ON THE ALARIS IV PUMP AND ATTEMPTED TO BE TURNED ON. IMMEDIATELY AFTER ATTEMPTING TO TURN THE PUMP ON IT STARTED ALARMING AND SAYING "CHANNEL ERROR". IT WAS ATTEMPTED TO BE RESTARTED BUT KEPT ALARMING THAT IT WAS DISCONNECTED. AT THIS TIME THE PATIENT'S PRIMARY PRESSOR (VASOPRESSIN) ALSO RANDOMLY SHUT OFF WITH NO ERROR MESSAGE ON THE SCREEN, IT JUST ABRUPTLY STOPPED. THE DOCTORS ARRIVED PROMPTLY TO THE BEDSIDE AND GAVE VERBAL ORDERS TO ADMINISTER 1MG EPINEPHRINE IV PUSH WHICH WAS GIVEN IMMEDIATELY PRIOR TO THE PATIENT GOING INTO A PULSELESS ELECTRICAL ACTIVITY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612453 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Required Intervention