BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS

    MDR report key: 18629507 · Received February 2, 2024

    Report

    Report Number
    18629507
    Event Type
    Other
    Date Received
    February 2, 2024
    Date of Event
    September 13, 2023
    Report Date
    September 19, 2023
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IN CRITICAL CONDITION, IN AND OUT OF VENTRICULAR FIBRILLATION (V-FIB) REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND CARDIAC SHOCK. INTRAVENOUS (IV) IN LEFT ANTECUBITAL (L AC). MEDICATION (AMIODARONE) WAS INFUSING FOR APPROXIMATELY 60 MIN WITHOUT DIFFICULTY. THE IV WAS CHECKED SEVERAL TIMES AND THE IV FLUSHED WITHOUT DIFFICULTY. OTHER MEDICATIONS WERE INFUSING THROUGH THE SAME IV WITHOUT DIFFICULTY. THE PUMP KEPT ALARMING IV OCCLUDED, PATIENT SIDE. THE PUMP LOOKED LIKE IT WAS BEING PRIED OPEN FROM THE TOP. THE DOOR WAS NOT LIKE THIS PRIOR. THE DOOR WAS OPENED, AND THE TUBING WAS FOUND WITH A LARGE BALLOON OF FLUID, APPROXIMATELY 10CC AT THE CONNECTION BETWEEN THE WHITE LINE AND THE BLUE CONNECTOR OVER THE AIR SENSOR. WHEN THE TUBING WAS REMOVED, THE CONNECTOR FELL APART INTO 3 PIECES. THE PATIENT DID NOT RECEIVE THE LIFESAVING MEDICATION FOR SOME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410128 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Unknown