BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 11776450 · Received May 4, 2021

    Report

    Report Number
    MW5101149
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 16, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BAXTER SIGMA SPECTRUM INFUSION PUMP PROGRAMED FOR CONTINUOUS NOREPINEPHRINE INFUSING AT 40 MCG/MIN. NURSE NOTED CHANGE IN PATIENT HEART RATE AND BLOOD PRESSURE, BOTH DECREASING. IMPROPER SHUTDOWN ALERT ON PUMP RECOGNIZED IMMEDIATELY AND MEDICATION CHANGED TO DIFFERENT PUMP. HR AND BP RECOVERED QUICKLY AFTER DOSE OF EPINEPHRINE AND RE-START OF NOREPINEPHRINE CONTINUOUS INFUSION. HISTORY LOG INDICATES: PUMP ON ¿ PWR STAT: BATT; BATTERY LOW ALERT GIVEN AND ONE MINUTE LATER PWR STAT: BATT IMPROPER SHUTDOWN ALERT GIVEN. DEVICE WAS CONNECTED TO AN ELECTRICAL OUTLET AT TIME OF EVENT, HISTORY LOG INDICATES RUNNING ON BATTERY POWER. ELECTRICAL PINS AND BATTERY CONTACTS EXAMINED AND NOTED TO HAVE CORROSION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670805 BAXTER SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION SIGMASPECTRUM WIRELESS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention