BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER PIGTAIL DUAL HTD WIRE 60W 1/CS

    MDR report key: 2422342 · Received January 19, 2012

    Report

    Report Number
    8030673-2012-00083
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    September 26, 2010
    Report Date
    September 30, 2010
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE RECEIVED WAS EVALUATED ACCORDING TO INTERNAL INSPECTION PROCEDURES AND IT WAS OBSERVED THAT THE CONNECTOR WAS MELTED (B)(4). THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE LOT NUMBER REPORTED IS INCORRECT; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. THE MANUFACTURING PROCESS FOR THIS PRODUCT WAS REVIEWED AND NO PROBLEMS WERE FOUND RELATED TO THE ISSUE REPORTED. A 100% INSPECTION IS PERFORMED ON THIS PARTICULAR PRODUCT CODE. THE PRODUCT SAMPLE WAS PROVIDED TO THE SUPPLIER, WHOSE RESPONSE WAS AS FOLLOWS: THE CABLE WAS TESTED USING THE APPROPRIATE TESTING EQUIPMENT FINDING THAT THE CABLE MET SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE FIELD OPERATION, PROBABLY STEMMING FROM POLARITY INVERSION OR VOLTAGE OVERLOAD. THEREFORE, IT IS NOT BELIEVED TO BE RELATED TO THE CIRCUIT. CAREFUSION 2200 INC. POST-MARKET SURVEILLANCE WAS HISTORICALLY MANAGED BY CARDINAL HEALTH VIA A TRANSITIONAL SERVICE AGREEMENT FROM SEPTEMBER 1, 2009, THROUGH JULY 1, 2011, SINCE CAREFUSION OFFICIALLY SPUN OFF FROM CARDINAL HEALTH AS OF SEPTEMBER 1, 2009. A RETROSPECTIVE REVIEW OF ALL COMPLAINTS DURING THIS TIMEFRAME WAS CONDUCTED BY THE NEW CAREFUSION CUSTOMER ADVOCACY CLINICAL TEAM IN ACCORDANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORTABLE (MDR) IN ACCORDANCE WITH 21 CODE OF FEDERAL REGULATION (CFR) PART 803.

    Description of Event or Problem · 1

    AN MR730 HEATER WAS USED ON AN ESPIRT VENTILATOR WITH AIRLIFE CIRCUIT # 9064-HS7. THE CIRCUIT WAS CONNECTED TO HEATER WIRE #0060-23. THE EXPIRATORY END OF THE HEATER WIRE AND THE CIRCUIT WIRE ADAPTER HAVE MELTED TOGETHER ON ONE SIDE. NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER PIGTAIL DUAL HTD WIRE 60W 1/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER) BZE CAREFUSION 0060-23 Y4J1067

    Patients

    Seq Age Sex Outcome Treatment
    1