BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3421244 · Received October 21, 2013

    Report

    Report Number
    8030673-2013-00065
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 23, 2013
    Report Date
    September 24, 2013
    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). SAMPLE IS IN THE PROCESS OF BEING SENT TO THE MANUFACTURING PLANT. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY:ONE OPEN SAMPLE (CIRCUIT) WAS RETURNED FOR EVALUATION AND PER VISUAL INSPECTION THE GREEN WIRE WAS OBSERVED ON THE EXPIRATORY LIMB OF THE CIRCUIT. THE SAMPLE WAS FUNCTIONALLY (RESISTANCE) TESTED PER CAREFUSION¿S PROCEDURE AND NO ISSUES WERE FOUND, READING WAS 26.6 OHMS FROM THE ALLOWED SPECIFICATION OF 24-27 OHMS. THE INTERNAL PRODUCTION RECORD FOR THE LOT REPORTED WAS REVIEWED AND NO ISSUES WERE OBSERVED. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH CAREFUSION SPECIFICATIONS. IN ADDITION, THE INTERNAL PRODUCTION RECORD OF THE WIRE SUBASSEMBLY WITH MANUFACTURING LOT 2380826 WAS REVIEWED AND NO ISSUES WERE OBSERVED. AT THIS TIME THERE IS NOT ANY EVIDENCE THAT CONFIRMS THAT OUR OPERATIVE PERSONNEL ARE CONTRIBUTING TO THIS FAILURE. DURING THE MANUFACTURING REVIEW IT WAS OBSERVED THAT PRODUCT IS 100% TESTED BY RESISTANCE FUNCTION, AND NO ASSEMBLY ERRORS WERE OBSERVED DURING CURRENT PRODUCTION BASED ON THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE FOR THE ISSUE REPORTED COULD NOT BE DETERMINED, BUT POSSIBLE CAUSES INCLUDE: THE WIRE MATERIAL RECEIVED FROM THE SUPPLIER COULD BE CAUSING THIS DEFECT. AFTER CAREFUSION¿S ENGINEERING REVIEW, IT WAS OBSERVED THAT THE GREEN COLOR ON THE WIRE COULD BE CAUSED BY A POSSIBLE CONTAMINATION AT THE SUPPLIER. AT THIS TIME, A REQUEST HAS BEEN SENT TO OUR SUPPLIER OF THE WIRE OF THE CIRCUITS TO INVESTIGATE THE ROOT CAUSE OF THIS ISSUE. THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: EXPIRATORY LIMB OF CIRCUIT ONLY, THE HEATER WIRES (4 INCHES) TURNED GREEN. NO INJURY TO PATIENT, RT SWITCHED OUT CIRCUIT WITH NO CHANGES TO PATIENT. HOSPITAL POLICY FOR CIRCUIT CHANGE OUT IS NO LONGER THAN 30 DAYS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 FROM CUSTOMER: I DID NOT HEAR ANY ALARMS GO OFF WHEN I NOTICED THE WIRE BUT I AM NOT SURE ABOUT ANY OTHER TIME BEFORE THAT. I HAVE NEVER COME ACROSS THIS ISSUE BEFORE AND THE OTHER RT'S THAT DAY SAID THAT THEY HAVE NOT EVER SEEN THIS BEFORE EITHER.  I AM NOT SURE HOW LONG THE PATIENT WAS ON THE CIRCUIT WITH THE WIRES GREEN. I NOTICED THE COLOR CHANGE WHEN I DID MY BCPAP ROUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539756 CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION RT4851-12 0000578386

    Patients

    Seq Age Sex Outcome Treatment
    1