BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3421724 · Received October 21, 2013

    Report

    Report Number
    9611451-2013-00824
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Report Date
    September 23, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONLY THE Y-PIECE AND THE PATIENT END CONNECTORS OF THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: NO DAMAGE WAS OBSERVED TO THE RETURNED PARTS. GLUE WAS VISIBLE AROUND THE EXPIRATORY GLUE PORT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130628. CONCLUSION: WE ARE UNABLE TO CONFIRM THE REPORTED PUNCTURED ON THE EXPIRATORY LIMB AS THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WAS NOT RETURNED TO US FOR FURTHER INVESTIGATION. DUE TO THE NATURE OF THE SUBJECT BREATHING CIRCUIT, THERE ARE POSSIBLE FAILURES THAT COULD MANIFEST IN THE STATED EVENT DESCRIPTION. WITHOUT THE COMPLAINT BREATHING CIRCUIT, WE WOULD NOT BE ABLE TO CONCLUDE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT. ALL RT340 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. IN ADDITION, TUBE WEIGHING AND BOND STRENGTH TESTING ARE PERFORMED EVERY 15 MINUTES. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THIS SUGGESTS THAT THE SUBJECT BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY LIMB OF THE 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 CAN BE 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 HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS PUNCTURED, CAUSING "NOISE AND LEAKS." THIS WAS OBSERVED WHILE A PATIENT WAS BEING INTUBATED AND VENTILATED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538546 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 130628

    Patients

    Seq Age Sex Outcome Treatment
    1