BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2638076 · Received July 2, 2012

    Report

    Report Number
    9611451-2012-00427
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 ADULT EVAQUA BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS PRESSURE TESTED AND VISUALLY INSPECTED. RESULTS: THE PRESSURE TEST RESULT WAS OUTSIDE OF THE REQUIRED SPECIFICATION. FURTHER INSPECTION REVEALED THAT THE EXPIRATORY EVAQUA TUBE WAS PUNCTURED ABOUT 17CM FROM THE ELBOW CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120413. CONCLUSION: BASED ON INSPECTION OF THE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY TUBE WAS PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. ALL RT340 ADULT BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS DAMAGED POST-PRODUCTION. THE KEY DIFFERENCE BETWEEN THE 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." (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN "ERROR" WAS REGISTERED ON THE VENTILATOR WHEN AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS CONNECTED. FURTHER INSPECTION REVEALED THAT THE BREATHING CIRCUIT HAD A SMALL HOLE ON THE "WHITE PLASTIC ADAPTER THAT IS ATTACHED TO THE Y-PIECE". THIS WAS OBSERVED PRIOR TO PATIENT USE.

    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 120413

    Patients

    Seq Age Sex Outcome Treatment
    1