BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA

    MDR report key: 1010241 · Received March 7, 2008

    Report

    Report Number
    MW5005835
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 7, 2008
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING A 3HR CHEMOTHERAPY INFUSION. APPROX 2HRS 15 MIN INTO INFUSION NOTED FLUID DRIPPING ON THE FLOOR. NOTED APPROX 1 INCH DIAMETER PUDDLE ON THE FLOOR AND THE INFUSION PUMP WAS WET. NOTED LIQUID DRIPPING FROM THE TUBING. IT WAS DETERMINED AT THIS TIME TO STOP THE INFUSION DUE TO RISK OF EXPOSURE OF CHEMOTHERAPEUTIC AGENT TO PT AND STAFF. PT DID NOT GET ANY OF THE AGENT ON HER, HOWEVER, STAFF MEMBER DID. PRODUCT WAS APPROPRIATELY DISCARDED, AGAIN DUE TO RISK INVOLVED WITH AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA NITROGLYCERIN PRIMARY IV TUBING FPA 561935H

    Patients

    Seq Age Sex Outcome Treatment
    1