BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 8411591 · Received March 12, 2019

    Report

    Report Number
    8411591
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    January 25, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BAXTER INTERNATIONAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IV PUMP ALARMING BATTERY FAILURE. MANUFACTURER RESPONSE FOR IV INFUSION PUMP, BAXTER SIGMA SPECTRUM INFUSION PUMP (PER SITE REPORTER). LOANER PUMPS WERE SENT AND STAFF TO REPAIR PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204664 SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER INTERNATIONAL, INC. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 30660 DA