BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 11640516 · Received April 9, 2021

    Report

    Report Number
    11640516
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 5, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN IV LINE WAS BEING REMOVED FROM A CAREFUSION 303, INC. ALARIS PUMP. IT WAS NOTED THAT THE IV LINE WOULD NOT SELF-CLAMP TO THE PUMP, ALTHOUGH THE IV LINE WAS STILL CONNECTED TO THE PATIENT. PITOCIN BOLUSED FOR APPROXIMATELY 5 SECONDS. ACCORDING TO THE CLINICAL/BIOMEDICAL TEAM, WHEN THE OPERATOR FORCES THE LATCH TO CLOSE, IT CAN BREAK THE IV CLAMP AND MAY AFFECT PROPER INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539386 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA