BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 7288918 · Received February 22, 2018

    Report

    Report Number
    7288918
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    September 22, 2008
    Report Date
    February 13, 2018
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS RECEIVING INSULIN BY INFUSION PUMP. IV RATE WAS CHECKED AND FOUND CORRECT OF 4.4 CC/HOUR AT 1855. AT 1910 THE PUMP RATE WAS 97 CC/HOUR. BLOOD SUGAR WAS CHECKED AND WAS AT 436. NNP (NEONATAL NURSE PRACTITIONER) WAS NOTIFIED. BLOOD SUGAR WAS RECHECKED AT 1930 AND IT WAS 303. NNP WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132929 SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 35700BAX

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR NO| NO OTHER THERAPIES