BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1901559 · Received November 10, 2010

    Report

    Report Number
    9616066-2010-00320
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S EXPERIENCE OF A BACK CHECK VALVE FAILURE WAS CONFIRMED. FUNCTIONAL TESTING PERFORMED SHOWED THAT BACKFLOW FROM THE SECONDARY BAG INTO THE PRIMARY BAG OCCURRED DUE TO A FAULTY CHECK VALVE. THE ROOT CAUSE OF THE CHECK VALVE BACKFLOW/BACK CHECK FAILURE IS DUE TO A POLYVINYLCHLORIDE (PVC) PARTICLE FOUND INSIDE THE CHECK VALVE THAT PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE MFG DATABASE WAS REVIEWED; NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD PERIOD OF THIS MODEL FOR THE FAILURE MODE REPORTED. EXP DATE: 05/01/2013 OR 06/01/2013. MFR DATE: 05/2010 OR 06/2010.

    Description of Event or Problem · 1

    A MINI-BAG CONTAINING KETOROLAC WAS HUNG AT 23:30. THE USER NOTICED THE SOLUTION FLOWING INTO THE DRIP CHAMBER AT A RAPID RATE. THE MINI-BAG WAS HUNG HIGHER THAN THE PRIMARY BAG. THE USER CLAMPED THE PRIMARY LINE AND OBSERVED THE MINI-BAG STILL DRIPPING AND NOTICED IT WAS FILLING THE DRIP CHAMBER OF THE PRIMARY LINE DESPITE THE CHECK VALVE. 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. 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SERIAL NUMBER UNK