BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 10747110 · Received October 28, 2020

    Report

    Report Number
    10747110
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 21, 2020
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNROLLED ROLLER CLAMP BELOW IV PUMP, AND TUBING FELL APART AT JUNCTION OF Y-SITE AND TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210166 ALARIS PUMP MODULE SMARTSITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 2426-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA