BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP

    MDR report key: 14732017 · Received June 16, 2022

    Report

    Report Number
    MW5110370
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 14, 2022
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALARIS PUMP WAS PROGRAMMED TO DRIP 60 ML/HR AND THE RATE WAS FASTER THAN PROGRAMMED. REVIEW OF THE PROGRAMMING LOGS SHOWED IT WAS PROGRAMMED CORRECTLY. CLINICAL ENGINEERING ANALYZED THE PUMP AFTER THE EVENT AND IT FAILED A PREVENTATIVE MAINTENANCE TEST (ACCURACY RATE FAILED AND WOULD NOT CALIBRATE). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226736 ALARIS PUMP PUMP, INFUSION FRN CAREFUSION 303, INC. 8100 LARGE VOLUME PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention