BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP PCU (BRAIN)

    MDR report key: 8843287 · Received July 29, 2019

    Report

    Report Number
    MW5088538
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 15, 2019
    Manufacturer
    BD/CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV FLUIDS DRIPPING OUT OF Y SITE PORT, UNK IF THE PT WAS RECEIVING FLUID. IV TUBING LOT #19055609.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628848 ALARIS PUMP PCU (BRAIN) INFUSION PUMP FRN BD/CAREFUSION 303, INC. 8100
    628849 PUMP LVP (MODULE) INFUSION PUMP FRN BD/CAREFUSION 303, INC. 8015
    628850 SET, I.V, FLUID TRANSFER SET, I.V, FLUID TRANSFER LHI UNK 19055609

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention