BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2830574 · Received November 13, 2012

    Report

    Report Number
    9611451-2012-00815
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT RT340 EXPIRATORY (EVAQUA) LIMB WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE EVAQUA EXPIRATORY LIMB REVEALED THAT THE CIRCUIT HAD BEEN STRETCHED AND DAMAGED, ABOUT 23CM FROM THE PATIENT END CONNECTOR. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE CUSTOMER HAD CONFIRMED THAT THE BREATHING CIRCUIT PASSED THE VENTILATION LEAK TEST PRIOR TO BEING USED ON A PATIENT AND WAS THUS UNDAMAGED AT THAT TIME. THEY FURTHER CONFIRMED THAT THE DAMAGE IN THE TUBING WAS NOTICED SHORTLY AFTER THEY HAD MOVED THE PATIENT. ADDITIONALLY, THEY CONFIRMED THAT THEY WERE USING A NON-FPH CIRCUIT HANGER TO SECURE THE BREATHING CIRCUIT. IT IS THEREFORE MOST LIKELY THAT THE DAMAGE OCCURRED WHILE THEY WERE MOVING THE PATIENT AND AS A RESULT OF USE OF THE THIRD PARTY CIRCUIT HANGER. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THE KEY DIFFERENCE BETWEEN THE EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF EVAQUA CIRCUITS SUCH AS THE RT340 IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOUR FROM EXPIRED VENTILATORY GAS TO PASS THROUGH. THE EVAQUA EXPIRATORY TUBE HAS A PROTECTIVE MESH WHICH PREVENTS DAMAGE TO THE WALLS OF THE TUBE, HOWEVER THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OBJECTS AND NON-FPH CIRCUIT HANGERS. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: -PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; -SET APPROPRIATE VENTILATOR ALARMS; -FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT RT340 EXPIRATORY (EVAQUA) LIMB WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE EVAQUA EXPIRATORY LIMB REVEALED THAT THE CIRCUIT HAD BEEN STRETCHED AND DAMAGED, ABOUT 23CM FROM THE PATIENT END CONNECTOR. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE CUSTOMER HAD CONFIRMED THAT THE BREATHING CIRCUIT PASSED THE VENTILATION LEAK TEST PRIOR TO BEING USED ON A PATIENT AND WAS THUS UNDAMAGED AT THAT TIME. THEY FURTHER CONFIRMED THAT THE DAMAGE IN THE TUBING WAS NOTICED SHORTLY AFTER THEY HAD MOVED THE PATIENT. ADDITIONALLY, THEY CONFIRMED THAT THEY WERE USING A NON-FPH CIRCUIT HANGER TO SECURE THE BREATHING CIRCUIT. IT IS THEREFORE MOST LIKELY THAT THE DAMAGE OCCURRED WHILE THEY WERE MOVING THE PATIENT AND AS A RESULT OF USE OF THE THIRD PARTY CIRCUIT HANGER. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THE KEY DIFFERENCE BETWEEN THE EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF EVAQUA CIRCUITS SUCH AS THE RT340 IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOUR FROM EXPIRED VENTILATORY GAS TO PASS THROUGH. THE EVAQUA EXPIRATORY TUBE HAS A PROTECTIVE MESH WHICH PREVENTS DAMAGE TO THE WALLS OF THE TUBE, HOWEVER THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OBJECTS AND NON-FPH CIRCUIT HANGERS. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: -PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; -SET APPROPRIATE VENTILATOR ALARMS; -FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT GAS LEAKED FROM THE EXPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT AFTER FIVE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340

    Patients

    Seq Age Sex Outcome Treatment
    1