BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM SIGMA

    MDR report key: 3982941 · Received August 1, 2014

    Report

    Report Number
    3982941
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 1, 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 UPSTREAM OCCLUSION ALARMS WITH INFUSION OF LASIX TO THE PATIENT. THIS FACILITY HAS HAD MULTIPLE SIMILAR PROBLEMS WITH THIS DEVICE OVER THE LAST YEAR. THE MANUFACTURER IS AWARE. THE CAUSE OF THE PROBLEMS REMAINS UNKNOWN. IN THESE CASES, THE LINE IS ABLE TO BE FLUSHED EASILY. THERE IS NO INDICATION OF AN OCCLUSION IN THE LINE OR AN IV INFILTRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451789 SPECTRUM SIGMA INFUSION PUMP FRN BAXTER HEALTHCARE INC 35700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR