BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 6348897 · Received February 22, 2017

    Report

    Report Number
    6348897
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 13, 2017
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON INSPECTION OF THE BECTON DICKINSON AND COMPANY PCA PUMP (WHICH REQUIRES A KEY TO OPEN AND CLOSE). HOSPITAL STAFF DISCOVERED A WEAK SPOT UNDER THE PLASTIC CHANNEL IN WHICH YOU ARE ABLE TO SLIP YOUR FINGER UNDER THE PLASTIC AND UNLOCK THE CHANNEL, ALLOWING THE MEDICATION TO BE REMOVED WITHOUT A KEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130874 ALARIS PCA MODULE PUMP, INFUSION, PCA MEA CAREFUSION 303, INC. 5120

    Patients

    Seq Age Sex Outcome Treatment
    1