BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1873514 · Received October 13, 2010

    Report

    Report Number
    9616066-2010-00292
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    June 13, 2010
    Report Date
    July 6, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF LEAK IN THE TUBING WAS CONFIRMED. THE LEAK WAS OBSERVED TO BE DUE TO A TEAR BELOW THE UPPER BLUE FITMENT OF THE SILICONE SEGMENT. A CRUSH MARK WAS NOTED ON THE UPPER BLUE FITMENT. THE CAUSE OF THE DAMAGE IN THE TUBING COULD NOT BE IDENTIFIED. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE POSSIBLE LOT NUMBERS WERE REVIEWED AND NO QUALITY ISSUE WERE NOTED DURING THE PRODUCTION BUILD PERIOD.

    Description of Event or Problem · 1

    NICU REPORTED, THE SET WAS LEAKING ABOVE THE UPPER FITMENT OF THE TUBING, BUT NO HOLE WAS FOUND. TPN WAS INFUSING. THE NURSE NOTED THE LEAK WHEN THE INFUSION WAS COMPLETED AND PUMP ALARMED FOR AIR IN THE LINE. NO PT HARM REPORTED. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK