BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCU

    MDR report key: 17808105 · Received September 22, 2023

    Report

    Report Number
    MW5146090
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 11, 2023
    Report Date
    September 20, 2023
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALARIS IV PUMP APPEARED TO BE BOLUSING PITOCIN THAT WAS SET AT A RATE OF 2 MILLIUNIT/MIN. REFERENCE REPORT: MW5146089.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072001 ALARIS PCU PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALARIS IV PUMP.