BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1770072 · Received July 8, 2010

    Report

    Report Number
    1770072
    Event Type
    Malfunction
    Date Received
    July 8, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CAREFUSION 303
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    DURING ADMINSTRATION OF CHEMOTHERAPY, NURSE NOTED CHEMO LEAKAGE ON UPPER FITTMENT BLOCK OF PUMP SET.====================== MANUFACTURER RESPONSE FOR INFUSION SET, CARDINAL HEALTH======================MANUFACTURER IS REQUESTING PUMP SET FOR EVALUATION. WILL BE SENDING TO THEM IN NEXT 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SET FPA CAREFUSION 303 * 07088123

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR CHEMOTHERAPY