BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3117208 · Received May 16, 2013

    Report

    Report Number
    9611451-2013-00397
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED. THE RESISTANCE OF THE EXPIRATORY LIMB HEATER WIRE WAS TESTED USING A CALIBRATED MULTIMETER. RESULTS: THE EXPIRATORY (EVAQUA2) LIMB WAS FOUND TO BE DISCOLOURED, WITH A BROWNISH COLOUR INSTEAD OF THE NORMAL WHITE. THE DISCOLOURATION WAS STRONGER NEAR THE PATIENT END CONNECTOR. NO RESIDUE WAS FOUND ON THE INSIDE OF THE LIMB. RESISTANCE TESTING OF THE HEATER WIRE REVEALED THAT IT WAS WITHIN SPECIFICATION AND WAS THUS HEATING CORRECTLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120717. CONCLUSION: THE HOSPITAL HAD REPORTED THAT THEY WERE NEBULISING ATROVENT, BUT IT DOES NOT APPEAR THAT THIS WAS THE CAUSE OF THE DISCOLOURATION, AS THE INSIDE OF THE TUBING IS LESS DISCOLOURED THAN THE OUTSIDE. THE DISCOLOURATION WAS MOST LIKELY CAUSED BY AN ANTI-OXIDANT THAT IS FOUND IN THE MATERIAL USED TO MANUFACTURE THE EVAQUA2 TUBE. THE ANTI-OXIDANT PREVENTS THERMAL DEGRADATION OF THE TUBING. THE EVAQUA2 TUBE HAS PASSED ALL REQUIRED BIOCOMPATIBILITY TESTS AND THE DISCOLOURATION HAS NO EFFECT ON THE PERFORMANCE OF THE BREATHING CIRCUIT. CONDENSATION IN THE BREATHING CIRCUIT CAN BE CAUSED BY VARIOUS ENVIRONMENTAL AND SETUP FACTORS. THE HOSPITAL REPORTED THAT THERE WAS A FAN PUT IN PLACE TO COOL THE PATIENT DOWN AS THE ROOM WAS VERY WARM. IT WAS POSITIONED ABOUT THREE FEET FROM THE PATIENT'S HEAD, AND THUS QUITE CLOSE TO THE RT380. IT IS LIKELY THAT THE FAN THAT WAS PLACED NEAR THE PATIENT'S HEAD CONTRIBUTED TO THE EXCESSIVE CONDENSATION. FAN USE IS QUITE UNCOMMON. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 CIRCUIT STATE THE FOLLOWING: CHECK BREATHING CIRCUITS FOR CONDENSATION EVERY 6 HOURS AND DRAIN IF REQUIRED. SINCE THE REPORTED COMPLAINT A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS VISITED THE HOSPITAL AND IS WORKING WITH HOSPITAL STAFF TO PROVIDE FURTHER TRAINING ON THE USE OF OUR HUMIDIFICATION SYSTEM AND CONDENSATION MANAGEMENT, WITH PARTICULAR REFERENCE TO THE USE OF FANS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BREATHING CIRCUIT HAS BEEN RECEIVED AT OUR MANUFACTURING FACILITY IN (B)(4) AND IS CURRENTLY BEING EVALUATED. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE EXPIRATORY LIMB OF AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS DISCOLOURED AND HAD EXCESSIVE CONDENSATION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS DISCOLOURED AND HAD EXCESSIVE CONDENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217477 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 120717

    Patients

    Seq Age Sex Outcome Treatment
    1