BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6974436 · Received October 24, 2017

    Report

    Report Number
    9616066-2017-01398
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 4, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A TEXIUM LEAK FROM THE CONNECTION OF THE TEXIUM VALVE ON THE SECONDARY SET TO THE SMARTSITE Y-PORT ON THE PRIMARY SET WAS NOT CONFIRMED. VISUAL INSPECTION AND FUNCTIONAL TESTING OBSERVED NO LEAKS AT THE CONNECTION BETWEEN TEXIUM VALVE AND SMARTSITE PORT. PRESSURE TESTING ALSO FOUND NO ANOMALIES WITH THE RETURNED SETS. THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    GTIN NUMBER FOR ITEM: (B)(4), LOT: 17016802 IS 10885403271021. CONCOMITANT MEDICAL PRODUCTS: 250ML BAXTER BAG, NDC 0338-0049-02, LOT NUMBER Y240176, EXP (B)(6), SODIUM CHLORIDE 0.9%, GEMCITABINE. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CHEMO LEAKED FROM THE CONNECTION OF THE TEXIUM VALVE ON THE SECONDARY SET TO THE SMARTSITE Y-PORT ON THE PRIMARY SET DURING AN INFUSION OF GEMCITABINE 2,160 MG/250 ML NW AT 613.616 ML/HR. THE TIME OF THE LEAK WAS NOT PROVIDED; HOWEVER, THE CUSTOMER REPORTED THE LEAK CAN OCCUR AT THE START OF THE INFUSION, DURING THE INFUSION OR NEAR THE END OF THE INFUSION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752764 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 24010-0007T 17016802

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR