BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 11398759 · Received March 2, 2021

    Report

    Report Number
    11398759
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 28, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAFF NOTICED FLUID ACCUMULATING AROUND THE CONNECTION BETWEEN THE MEDICATION SYRINGE AND TUBING. A POOL OF STICKY LIQUID WAS ALSO NOTED TO BE ON THE FLOOR. ONCE THIS WAS DISCOVERED, A NEW PGE SYRINGE WAS OBTAINED FROM PHARMACY. UPON CLOSER ASSESSMENT OF PREVIOUSLY HUNG SYRINGE AND TUBING, A LONG CRACK WAS SEEN RUNNING DOWN CONNECTION PORT OF TUBING WHICH WAS THE SOURCE OF THE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295723 ALARIS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 10014914

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA