BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3283415 · Received August 12, 2013

    Report

    Report Number
    8030673-2013-00048
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 15, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE HAS ARRIVED AT THE MANUFACTURING PLANT AND EVALUATION IS ANTICIPATED. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WOULD BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE SAMPLE (EXPIRATORY LINE) WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION, THE MELTING WAS OBSERVED. NO ISSUES WERE FOUND DURING THE REVIEW OF INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. THIS INCLUDES REVIEW OF ALL RAW MATERIAL (WIRE) USED DURING THE MANUFACTURE OF THE LOT INVOLVED. IN ADDITION, NO ISSUES WERE OBSERVED DURING THE MANUFACTURING PROCESS REVIEW. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH CAREFUSION SPECIFICATIONS. THE WIRE OF THE CIRCUIT WAS TESTED IN ACCORDANCE WITH OUR INSPECTION PROCEDURE WERE A NORMAL TOLERANCE RANGES BETWEEN 24 AND 27 OHMS AND THIS CIRCUIT WAS FOUND WITHIN SPECIFICATION AT 26.3 OHMS. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THE ISSUE REPORTED COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSES FOR THE REPORTED CONDITION CAN BE RELATED TO INSULATION I.E. THE CIRCUIT COVERED WITH A BLANKET WHICH CAN LEAD TO A MELT AND LEAK AND/OR THE USE OF A NON-SPECIFIED HUMIDIFIER WITH THIS PRODUCT AS DIRECTED BY THE INSTRUCTIONS FOR USE (IFU). CAREFUSION RECOMMENDS CUSTOMERS FOLLOW CAUTIONS AND WARNINGS LISTED ON THE IFU TO AVOID ANY ISSUES: CAUTIONS: 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. PLEASE NOTE THAT THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.

    Description of Event or Problem · 1

    CUSTOMER (RESPIRATORY DIRECTOR, MS. (B)(6))REPORTED:  ONE OF OUR RESPIRATORY THERAPIST REPORTED THAT CIRCUIT, RT4851-12, "MELTED" AT A POINT APPROX 6" FROM THE "Y" ADAPTER ON THE EXPIRATORY LIMB.  NO PATIENT HARM OR INJURY OCCURRED.  THIS WAS THE REPLACEMENT CIRCUIT FOR PQR: (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: ON (B)(6) 2013 THE MOTHER OF THE PATIENT STATED THAT IT LOOKED LIKE THE CIRCUIT HAD MELTED. UPON REVIEW, IT WAS VISUALLY CONFIRMED THAT THERE THE CIRCUIT APPEARED MELTED.  NO ALARMS ALARMED AND THE CIRCUIT WAS REPLACED.  A SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385413 CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION RT4851-12 0000527251

    Patients

    Seq Age Sex Outcome Treatment
    1