BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMART SITE

    MDR report key: 1870357 · Received September 23, 2010

    Report

    Report Number
    1870357
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 16, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S IV TUBING CARTRIDGE HAD CRACKED AND A BOTTLE OF MEDICATION WENT TO THE FLOOR. SINCE THIS EVENT, MULTIPLE SIMILAR EVENTS HAVE BEEN REPORTED. SOME OF THE TUBINGS APPEAR TO HAVE HAIRLINE CRACKS IN THE PLASTIC ALONG THE SIDE OF THE CARTRIDGE THAT FITS INTO THE PUMP. OTHERS HAVE NO VISIBLE CRACKS, BUT ALSO LEAK. TWO LOT NUMBERS HAVE BEEN IDENTIFIED AND THE REP EVALUATED AND DETERMINED THAT IT WAS PRODUCT FLAW AND NOT USER ERROR. PRODUCT TO BE REMOVED FROM FACILITY AND REPLACEMENT PRODUCT TO BE USED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THROUGH COMPANY, FACILITY AND REP INVESTIGATION IT WAS DETERMINED THAT THIS IS A PRODUCT FLAW AND NOT STAFF USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SMART SITE INFUSION SET FPA CAREFUSION * 10046344 AND 10036559

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR