BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI PC-2

    MDR report key: 1051920 · Received May 12, 2008

    Report

    Report Number
    1051920
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    July 12, 2007
    Report Date
    May 7, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INFUSION PUMP HAD A MAJOR FAILURE OF THE PUMP MECHANISM ALARM CIRCUIT. THE LOWER PUMP BRACKET HAD BEEN BROKEN AND SEPARATED FROM THE HINGE, ALLOWING A FREE FLOW CONDITION. THE PUMP MECHANISM ALARM CIRCUIT'S MICROSWITCH WAS STUCK IN THE CLOSED POSITION, AND THEREFORE DID NOT TRIP THE PUMP ALARM. THE LOWER PUMP BRACKET DAMAGE WAS MOST LIKELY CAUSED BY THE INFUSION PUMP BEING DROPPED AND SUSTAINING A SEVERE IMPACT ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PC-2 PUMP, IV FRN ALARIS MEDICAL SYSTEMS, INC. 1325D *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA