BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2040490 · Received April 5, 2011

    Report

    Report Number
    9611451-2011-00216
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. MANUFACTURER NARRATIVE: METHOD: ONLY ONE EVAQUA EXPIRATORY TUBE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) NEW ZEALAND FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED FOR LEAKS. RESULTS: THE VISUAL INSPECTION REVEALED A HOLE IN THE RETURNED EVAQUA TUBE. THE TUBE FAILED THE PRESSURE TEST AS IT WAS LEAKING FROM THE HOLE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100819. CONCLUSION: BASED ON OUR EVALUATION, IT IS LIKELY THAT THE EVAQUA EXPIRATORY TUBE HAS BEEN PULLED, CREATING A HOLE AND RESULTING IN THE REPORTED LEAK. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS PUNCTURED POST-PRODUCTION. THE KEY DIFFERENCE BETWEEN FISHER & PAYKEL HEALTHCARE'S EVAQUA BREATHING CIRCUITS AND THE 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 VAPOR FROM EXPIRED VENTILATORY GASES 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 OBJECTS SUCH AS CIRCUIT HANGERS. THE RT340 USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENT: "SET APPROPRIATE VENTILATOR ALARMS", AS VENTILATOR ALARMS ALERT THE USER TO A LEAK IN THE SYSTEM AND ALLOWS CAREGIVERS TO ACT BY REPLACING THE BREATHING CIRCUIT ACCORDING TO THEIR STANDARD PROCEDURES. IT ALSO ADVISE THE USER TO "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE". OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING ADULT EVAQUA BREATHING CIRCUIT LEAKS HAS A RATE OF OCCURRENCE OF 78 DEVICES PER MILLION SOLD IN THE LAST YEAR TO THE END OF (B)(6) 2011.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE EXPIRATORY TUBES OF TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE FOUND LEAKING. THIS WAS NOTICED PRIOR TO PATIENT 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 LIMITED RT340 100819

    Patients

    Seq Age Sex Outcome Treatment
    1