BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP IV ADMINISTRATION SET

    MDR report key: 1999980 · Received February 16, 2011

    Report

    Report Number
    9616066-2011-00051
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    April 22, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S EXPERIENCE OF SECONDARY INFUSION TOO QUICKLY WAS NOT CONFIRMED, HOWEVER, TESTING CONFIRMED SECONDARY SOLUTION BACKING UP INTO THE PRIMARY SOLUTION. NO FAULT WAS FOUND WITH THE CHECK VALVE DURING THE SUPPLIER'S INVESTIGATION. THE CAUSE OF THE SECONDARY SOLUTION BACKING UP INTO THE PRIMARY SOLUTION CONTAINER WAS DUE TO A CHECK VALVE FAILURE. THE ROOT CAUSE OF THE FAILURE WAS NOT IDENTIFIED. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THIS DEVICE WAS BUILT BETWEEN FEBRUARY 25, 2010 AND MARCH 1, 2010. EXPIRATION DATE EITHER 02/01/2015 OR 03/01/2015.

    Description of Event or Problem · 1

    BIOMED CALLED WITH REPORT OF AN IV PIGGYBACK SET UP TO ADMINISTER 100ML/HR AS A SECONDARY AND INFUSED IN 5 MINUTES. BIOMED RETAINED THE EQUIPMENT INCLUDING 50ML BAG OF 0.9 SODIUM CHLORIDE WITH 1 GRAM VIAL OF CEFAZOLIN. BIOMED'S TESTING DID NOT FIND ANY ISSUES WITH THE DISPOSABLES. NO PATIENT HARM WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP IV ADMINISTRATION SET FPA CAREFUSION CORPORATION 72033E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS SE PUMP, SERIAL NUMBER (B)(4)