BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IV PUMP

    MDR report key: 1886649 · Received October 6, 2010

    Report

    Report Number
    1886649
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PUMP AUTOMATICALLY SHUT DOWN. STATED "IMPROPER SHUT DOWN". PUMP ALSO CONTINUOUSLY BEEPED FOR BATTERY ALERT, EVEN THOUGH PUMP WAS PLUGGED IN. HAD TO USE BASIC MODE DUE TO POTASSIUM PHOSPHATE IV NOT IN SIGMA PUMP DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM IV PUMP INFUSION PUMP FRN SIGMA * LIB050310

    Patients

    Seq Age Sex Outcome Treatment
    1 *