BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2000597 · Received February 2, 2011

    Report

    Report Number
    9616066-2011-00039
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    October 28, 2010
    Report Date
    November 9, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 02/02/2011. (B)(4). PRODUCT WAS EVALUATED AND CUSTOMER'S EXPERIENCE OF LEAKING WAS CONFIRMED. LEAKING OCCURRED AT THE ENGAGEMENT BETWEEN THE VINYL TUBING TO Y-SITE ENGAGEMENT OF THE FIRST SMARTSITE. CRACKS WERE NOT OBSERVED ANYWHERE ON THE RETURNED SET. THE CAUSE OF THE LEAK WAS IDENTIFIED AS INSUFFICIENT SOLVENT APPLIED AT THE VINYL TUBING TO Y-SITE ENGAGEMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 3% NS IV WAS INITIATED AT 20:38. AT 21:00 IV TUBING WAS FOUND TO BE LEAKING WITH A PUDDLE OF IV SOLUTION ON FLOOR UNDER IV POLE. CRACK WAS NOTED IN TUBING BETWEEN AIR VALVE (PRESUMED TO BE BACK CHECK VALVE) AND UPPER NEEDLE-FREE PORT. IT WAS REPORTED PRODUCT WAS IN USE FOR 30 MINUTES. NEW IV PRIMARY LINE AND IV MAINTENANCE SOLUTION WAS SET UP. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SERIAL NUMBER UNK| ALARIS PC UNIT, SERIAL NUMBER UNK