BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS IV INFUSION PUMP

    MDR report key: 11163178 · Received January 12, 2021

    Report

    Report Number
    MW5098783
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    November 24, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BD ALARIS/CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON INSULIN DRIP IN LABOR; INSULIN RATE HAD BEEN VERIFIED BY 2 RN'S AT THE BEGINNING OF ADMINISTRATION WITH FULL BAG OF 100ML, MEDICATION HAD BEEN SCANNED PROPERLY AND PUMP PROGRAMMED PROPERLY. PATIENT EXPRESSED TO RN THAT SHE WAS FEELING WEAK; BLOOD GLUCOSE OBTAINED (RESULT 101); PATIENT WAS PLACED IN BED, INSULIN DRIP RATE CHANGED TO 0; RN NOTED THAT THE BAG OF INSULIN WAS EMPTY, AND AN EXTENSIVE AMOUNT OF AIR WAS IN THE LINE. THE PUMP NEVER BEEPED THAT AIR WAS IN THE LINE. THE PUMP INVESTIGATION REVEALED THAT THE PUMP WAS PROGRAMMED CORRECTLY, AND THE ADMINISTERED AMOUNT WAS .44ML DESPITE THE ENTIRE 100ML HAVING FLOWED INTO THE PATIENT. THE PUMP HAD BEEN SEQUESTERED AND ALL TUBING LEFT INTACT WHEN EVALUATED, THE TUBING WAS LOADED IN THE CHAMBER CORRECTLY AND NO ISSUES IDENTIFIED WITH THE TUBING. CLINICAL ENGINEERING FOUND NO ISSUES WITH THE PUMP EITHER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53803 BD ALARIS IV INFUSION PUMP PUMP, INFUSION FRN BD ALARIS/CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1