BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1901015 · Received October 18, 2010

    Report

    Report Number
    1901015
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 18, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    "EQUIPMENT MALFUNCTION" ALARM ON ALARIS PUMP SOUNDED. TECHNICIAN RESPONDED FIRST & WAS UNFAMILIAR WITH WHAT SHE SHOULD DO. RN RESPONDED & REMOVED MALFUNCTIONING EQUIPMENT WITH ALL IV SUPPLIES ATTACHED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT APPLICABLE====================== MANUFACTURER RESPONSE FOR INFUSION PUMP, INFUSION PUMP======================AWAITING RESPONSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP FRN CAREFUSION 7130 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR