BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2232146 · Received September 2, 2011

    Report

    Report Number
    9611451-2011-00541
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 3, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    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 RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE VISUAL INSPECTION REVEALED A HOLE ON THE EXPIRATORY EVAQUA LIMB APPROXIMATELY 52CM AWAY FROM THE PATIENT END CONNECTOR. THE HOLE HAD THE APPEARANCE OF HAVING BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. THE PRESSURE TEST REVEALED EXCESSIVE LEAK, DUE TO THE OBSERVED DAMAGE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: BASED ON INSPECTION OF THE HOLE, THE COMPLAINT EVAQUA EXPIRATORY LIMB OF THE BREATHING CIRCUIT WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. 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, POSSIBLY DURING STORAGE OR SETUP. 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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. THE VISUAL INSPECTION REVEALED A HOLE ON THE EXPIRATORY EVAQUA LIMB APPROXIMATELY 52CM AWAY FROM THE PATIENT END CONNECTOR. THE HOLE HAD THE APPEARANCE OF HAVING BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. THE PRESSURE TEST REVEALED EXCESSIVE LEAK, DUE TO THE OBSERVED DAMAGE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. BASED ON INSPECTION OF THE HOLE, THE COMPLAINT EVAQUA EXPIRATORY LIMB OF THE BREATHING CIRCUIT WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. 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, POSSIBLY DURING STORAGE OR SETUP. 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 (B)(4), HOWEVER THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OBJECTS AND 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; (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE DRAEGER EVITA XL VENTILATOR LEAK TEST DURING SET UP.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE DRAEGER EVITA XL VENTILATOR LEAK TEST DURING SET UP.

    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 110428

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER| MR850 RESPIRATORY HUMIDIFIER| DRAEGER EVITA XL VENTILATOR| DRAEGER EVITA XL VENTILATOR