BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS IV PUMP

    MDR report key: 20189328 · Received September 9, 2024

    Report

    Report Number
    MW5159425
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 24, 2024
    Report Date
    September 5, 2024
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT RECEIVED APPROXIMATELY 250 ML OF STARTER TPN FLUID OVER A 2¿3-HOUR PERIOD CAUSING FLUID OVERLOAD, PULMONARY EDEMA AND HEMORRHAGE AS WELL AS HYPERGLYCEMIA AND ELECTROLYTE IMBALANCE. IV PUMP DID NOT ALARM TO ADVISE FLUID INFUSING AT INCORRECT RATE. CAREFUSION ALARIS IV PUMP. INFANT WAS INTUBATED, STARTED ON INSULIN DRIP, GIVEN LASIX TWO DOSES, AND HYPOTONIC IV FLUIDS. INFANT RESPONDED WELL AND WAS EXTUBATED THE NEXT DAY AND LABS WERE BACK TO BASELINE. ASSET NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574580 ALARIS IV PUMP PUMP, INFUSION FRN CAREFUSION 303, INC. 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Required Intervention