BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2908544 · Received January 10, 2013

    Report

    Report Number
    9611451-2013-00027
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 13, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT345 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT345 ADULT EVAQUA BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE EVAQUA EXPIRATORY LIMB WAS VISUALLY INSPECTED. RESULTS: A HOLE WAS FOUND IN THE EVAQUA EXPIRATORY LIMB ABOUT 18.5CM AWAY FROM THE PATIENT END CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120827. CONCLUSION: BASED ON THE NATURE OF THE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY LIMB WAS PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. ALL RT345 ADULT 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 RT345 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 ADULT EVAQUA 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). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEATLHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT345 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE LEAK TEST ON A VENTILATOR. THEY FURTHER REPORTED A PINHOLE IN THE EVAQUA EXPIRATORY LIMB. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN RT345 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE LEAK TEST ON A VENTILATOR. THEY FURTHER REPORTED A PINHOLE IN THE EXPIRATORY LIMB. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14646 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT345 120827

    Patients

    Seq Age Sex Outcome Treatment
    1