BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS

    MDR report key: 2420543 · Received January 18, 2012

    Report

    Report Number
    8030673-2012-00076
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: THIS IS REPORT ONE OF TWO AS TWO SAMPLES WERE RECEIVED. THE SAMPLES RECEIVED WERE EVALUATED ACCORDING TO INSPECTION PROCEDURES AND IT COULD BE OBSERVED THAT TWO OF THE FIVE HEATED WIRE CIRCUITS WERE MELTED IDENTIFIED WITH LOT NUMBER Y10H1740. THEREFORE, WE WERE ABLE TO CONFIRM THE ISSUE REPORTED. THE SAMPLES COULD NOT BE TESTED FUNCTIONALLY WERE CONTAMINATED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REPORTED WAS REVIEWED AND IN LOT NUMBER Y10C1173, IT WAS FOUND THAT THERE WAS A DEFECT IN PART NUMBER 57-955; HOWEVER, THE RE-WORK COMPLETED IS UNRELATED TO THE DEFECT NOTED IN THIS REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH INTERNAL PROCEDURES. THE MANUFACTURING PROCESS WAS REVIEWED AND NO PROBLEMS WERE FOUND RELATED TO THE ISSUE REPORTED. AT THIS MOMENT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE; HOWEVER, WARNINGS IN THE PRODUCT LABEL OF THE CIRCUIT INDICATES THE FOLLOWING: CAUTION DO NOT USE THIS CIRCUIT WHERE GAS TEMPERATURE AT THE OUTLET OF THE HUMIDIFIER EXCEEDS 68 DEGREES CELSIUS. DO NOT USE THE HEATED WIRE CIRCUIT WITHOUT GAS FLOW. DO NOT PLACE MATERIAL ON OR AROUND THE HEATED WIRE TUBING. WARNINGS: AVOID CONTACT WITH PATIENT SKIN. DO NOT STRETCH THE TUBING. DO NOT SOAK, RINSE WASH, OR STERILIZE THIS PRODUCT.

    Description of Event or Problem · 1

    HEATED WIRE MELTED CIRCUIT AND CAUSED A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER) BZE CAREFUSION RT4851-12 Y10H1740

    Patients

    Seq Age Sex Outcome Treatment
    1