BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO

    MDR report key: 2110293 · Received May 19, 2011

    Report

    Report Number
    2110293
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHILE IRON WAS INFUSING VIA PUMP, R.N. NOTICE THAT THE IRON WAS BACKING UP INTO THE PRIMARY SALINE BAG (APPROX. 60CC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO INTRAVASCULAR SET FPA BAXTER 2C8519S *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR