BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IV PUMP

    MDR report key: 1886648 · Received October 6, 2010

    Report

    Report Number
    1886648
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 24, 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

    SPECTRUM PUMP ALARMED FOR PUMP FAILURE, THEN SHUT DOWN WITH MESSAGE ON SCREEN "READY". A 1.3 INSULIN WAS RUNNING AT THE TIME IT SHUT DOWN. THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM IV PUMP IV PUMP FRN SIGMA 35724 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *