BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1892562 · Received November 3, 2010

    Report

    Report Number
    9616066-2010-00319
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    July 20, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF SECONDARY FLUID BACKING UP INTO THE PRIMARY BAG WAS CONFIRMED THROUGH FUNCTIONAL TESTING AT CAREFUSION'S LAB. THE SAMPLE WAS SENT TO THE CHECK VALVE SUPPLIER. THEIR TESTING CONFIRMED A CHECK VALVE FAILURE. DISASSEMBLY OF THE CHECK VALVE PART RESULTED IN MANY CLEAR PARTICLES FOUND. THE PARTICLES WERE FOUND TO BE IN THE FLUID PATH AND COVERED BOTH SIDES OF THE DISK. THE PARTICLES WERE IDENTIFIED AS PHENYTOIN (DILANTIN) IN POTASSIUM BROMIDE. THE ROOT CAUSE OF THE CHECK VALVE FAILURE WAS DUE TO PARTICLES THAT PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING AREA. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE MFG DATABASE WAS REVIEWED; NO QUALITY ISSUES WERE NOTED DURING THE PRODUCTION BUILD PERIOD FOR THIS MODEL FOR THE FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    IN THE ICU, AN RN SET UP A DILANTIN INFUSION. SHE PLACED THE PRIMARY SET INTO THE PUMP AND OPENED UP THE ROLLER CLAMP AND ALL OF THE SECONDARY FLOWED INTO THE PRIMARY BAG. NO PT HARM. 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. 2420-0500 UNK

    Patients

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