BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 2010893 · Received February 25, 2011

    Report

    Report Number
    2010893
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECIEVING RITUXAN INFUSION FOR TREATMENT OF MALIGNANCY. RITUXAN INFUSING VIA ALARIS SMART PUMP USING LOW-SORB ALARIS TUBING. PUMP WAS BEEPING "AIR IN LINE" SEEING THE AIR REMOVED THE CASSETTE FROM THE PUMP. IMMEDIATELY THE PUMP TUBING DISCONNECTED RESULTING IN A LOSS OF 100-200ML OF RITUXAN. THIS REQUIRED CHEMOTHERAPY SPILL CLEAN UP PROCEDURES.====================== MANUFACTURER RESPONSE FOR SMARTSITE INFUSION SET, CAREFUSION======================AWAITING A FORMAL REPORT OF ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE INFUSION PUMP FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR