BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM

    MDR report key: 4169097 · Received October 7, 2014

    Report

    Report Number
    4169097
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    August 22, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    MULTIPLE ALARMS RELATED TO UPSTREAM OCCLUSION. PATIENT HAD A TKO LINE AND HAD ANTIBIOTIC RUNNING. THIS REQUIRES MULTIPLE INTERVENTIONS AND DELAYS ANTIBIOTIC INFUSION. THIS FACILITY HAS HAD ONGOING SIMILAR EVENT ISSUES WITH THIS DEVICE. THE MANUFACTURER HAS BEEN NOTIFIED. PROBLEMS PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626292 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER HEALTHCARE INC 35700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR