BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 2251701 · Received August 31, 2011

    Report

    Report Number
    9616066-2011-00496
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Report Date
    August 10, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET HAS BEEN RECEIVED AND AN INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SET TO BE DAMAGED/BROKEN. CUSTOMER STATED THE FOLLOWING: CHEMO WAS USED; Y CONNECTOR ATTACHED TO PT. BLOOD NOTED TO BE BACKING UP IN THE Y. RN ATTEMPTED TO FLUSH Y CONNECTOR AND WATER CAME OUT OF THE OTHER SIDE OF THE Y WHICH WAS WHERE THE WATER WAS COMING OUT. HOSPITAL REPORTED "NO CONSEQUENCES EXCEPT Y REQUIRED CHANGING; CHEMO WAS PRESENT IN Y BUT NO CHEMO SPILL OCCURRED." THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS EXTENSION SET FPA CAREFUSION CORPORATION 10794983 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK