BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1873444 · Received October 14, 2010

    Report

    Report Number
    9616066-2010-00298
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    June 10, 2010
    Report Date
    September 3, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF TUBING LEAKING WAS CONFIRMED. THE LEAKING WAS FROM A PINHOLE APPROX 0.0425 INCHES LONG IN THE SILICONE TUBING BELOW THE UPPER FITMENT. THE CAUSE OF THE LEAK WAS NOT IDENTIFIED. EXPIRATION DATE: 08/01/2012 OR 09/01/2012. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE POSSIBLE LOT NUMBERS WERE REVIEWED AND NO QUALITY ISSUES WERE NOTED DURING THE PRODUCTION BUILD PERIOD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SILASTIC SECTION OF TUBING LEAKING JUST BELOW BLUE ACORN-SHAPED PIECE AT JUNCTION OF PUMP FITMENT INSIDE PUMP CHAMBER. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10013072 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SERIAL # UNK