BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2230926 · Received July 20, 2011

    Report

    Report Number
    9616066-2011-00415
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF A LEAKING FILTER WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR HOLES AND TEARS, INCOMPLETE BONDING ENGAGEMENT IN THE TUBING AND DAMAGE AT THE SMARTSITE VALVE. THE DAMAGE WAS FOUND AT THE FILTER VENT OUTLET. THE SET WAS SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION. THE SUPPLIER FOUND A HOLE IN THE VENT MEMBRANE AND DARK SPOTS ON BOTH SIDES OF THE VENT MEMBRANE. THE CAUSE OF THE DARK SPOTS WAS NOT IDENTIFIED. THE CAUSE OF THE LEAK WAS IDENTIFIED AS A DAMAGED VENT MEMBRANE. THE ROOT CAUSE OF THE DAMAGE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CHEMOTHERAPY LEAK FROM FILTER. INFUSION WAS STARTED ON (B)(6) 2011 AT 1300 AND SOMETIME IN THE EVENING OR EARLY MORNING, THE PATIENT NOTED LEAKING/SEEPAGE FROM FILTER OF IV SET. THE INFUSION WAS STOPPED AND THE TUBING REMOVED WITHOUT INCIDENT. NO PATIENT OR STAFF HARM OCCURRED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2465-0007 1005559

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 1000ML BAG OF 0.9% SODIUM CHLORIDE: LOT 94-024-JT| EXPIRATION DATE: OCTOBER 01, 2012