BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY IV PLUM SET

    MDR report key: 2170897 · Received July 12, 2011

    Report

    Report Number
    2170897
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 12, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD CONCURRENT INFUSION OF LEUCOVORIN & OXALIPLATIN INFUSING. PUMP ALARMED "AIR IN LINE" WHEN RN WENT INTO ROOM. LEUCOVORIN BAG WAS EMPTY AND AIR IN TUBING WAS APPROXIAMATELY 15" BELOW THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY IV PLUM SET INTRAVASCULAR TUBING FPA HOSPIRA * 02079 5H

    Patients

    Seq Age Sex Outcome Treatment
    1 *