BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 2081648 · Received April 27, 2011

    Report

    Report Number
    9616066-2011-00143
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/27/2011. (B)(4). NO PRODUCT WAS RETURNED FOR EVAL; CUSTOMER STATED THE PRODUCT WAS DISCARDED AT THE FACILITY. THE LOT NUMBER WAS NOT IDENTIFIED. UNABLE TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S REPORTED PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PT'S TOTAL PARENTERAL NUTRITION (TPN) DISCONNECTED FROM Y-CONNECTOR WHERE IT IS ATTACHED TO SMARTSITE NEEDLE FREE VALVE PORT ON BROVIAC. PT CARE TECHNICIAN (PCT) FOUND TPN ON FLOOR. NOTIFIED RN, RN HEPLOCKED PT'S CENTRAL LINE PER POLICY AND NOTIFIED PHYSICIAN, MAINTENANCE FLUIDS ORDERED. NO PT HARM REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXTENSION SET FPA CAREFUSION CORPORATION 20019E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO SMARTSITE NEEDLE FREE VALVE: 2000E, LOT NUMBER UNK