BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2839509 · Received October 26, 2012

    Report

    Report Number
    2839509
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 25, 2012
    Manufacturer
    FENWAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE REALIZED APPROXIMATELY HALFWAY THROUGH INFUSION THAT THE SALINE BAG (USED TO PRIME LINE) WAS ALSO RUNNING WITH PRODUCT. THE NORMAL SALINE BAG WAS CLAMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SET, BLOOD TRANSFUSION FPA FENWAL, INC. 85412046273 4C6772

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR