BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 3150834 · Received June 6, 2013

    Report

    Report Number
    9611451-2013-00451
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. METHOD: THE COMPLAINT RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) AND VISUALLY INSPECTED. RESULTS: A HOLE WAS FOUND IN THE EVAQUA (EXPIRATORY) LIMB OF THE COMPLAINT BREATHING CIRCUIT, APPROXIMATELY 26MM AWAY FROM THE PATIENT END CONNECTOR. CONCLUSION: BASED ON INSPECTION OF THE HOLE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY LIMB WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO BEING RELEASED FOR DISTRIBUTION. IN ADDITION, TUBING WEIGHT AND BOND STRENGTH TESTS ARE PERFORMED EVERY 15 MINUTES. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS DAMAGED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE KEY DIFFERENCE BETWEEN FPH'S 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.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED FROM A HOSPITAL IN (B)(6) FOR AN RT340 ADULT BREATHING CIRCUIT. UPON INVESTIGATION OF THE COMPLAINT DEVICE ON (B)(6) 2013, THIS COMPLAINT WAS CONSIDERED VIGILANCE REPORTABLE AS A HOLE WAS FOUND ON THE EXPIRATORY LIMB OF THE RT340 CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251238 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120503

    Patients

    Seq Age Sex Outcome Treatment
    1