BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE GRAVITY SET

    MDR report key: 1813188 · Received August 19, 2010

    Report

    Report Number
    9616066-2010-00228
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    February 22, 2010
    Report Date
    February 23, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K780130
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF SET DISCONNECTED BELOW THE SPIKE WAS CONFIRMED. THE CAUSE OF THE DISCONNECTION WAS IDENTIFIED AS INSUFFICIENT APPLICATION OF SOLVENT AT THE AFFECTED SPIKE-TO-TUBING JOINT DURING THE MANUFACTURING PROCESS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD FOR THE LOT NUMBER REPORTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE SET DISCONNECTED BELOW THE SPIKE DURING A CHANGE OF FLUID BAG. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE GRAVITY SET FPA CAREFUSION CORP 82113E 09095368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMINI PUMP, SERIAL # UNK