BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO

    MDR report key: 2161743 · Received July 11, 2011

    Report

    Report Number
    2161743
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    March 3, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BAXTER
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVING INFUSION OF CHEMOTHERAPY WHEN HUSBAND SOUGHT ASSISTANCE FROM NURSE. HUSBAND STATED THAT THERE WAS A POOL OF LIQUID ON THE FLOOR. NURSE INVESTIGATED AND FOUND A 4 FOOT BY 1 FOOT AREA OF BLOOD AND CHEMO SOLUTION ON THE FLOOR WHICH HAD APPARENTLY DRIPPED DOWN FROM THE IV TUBING ONTO THE PATIENT'S SWEATER, DOWN THE SIDE OF THE CHAIR AND ONTO THE FLOOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR CHEMOTHERAPY