BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2791952 · Received October 15, 2012

    Report

    Report Number
    9611451-2012-00730
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    September 17, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOTH COMPLAINT DEVICES WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR EVALUATION. CIRCUIT #1 WAS FROM LOT 120612, WHILE CIRCUIT #2 HAD NO LOT NUMBER INFORMATION. THE CIRCUITS WERE VISUALLY EXAMINED AND PRESSURE TESTED TO CHECK FOR LEAK. RESULTS: VISUAL INSPECTION OF CIRCUIT #1 REVEALED NO DAMAGE OF ANY KIND. VISUAL INSPECTION OF CIRCUIT #2 REVEALED A HOLE IN THE EVAQUA EXPIRATORY LIMB, ABOUT 73CM FROM THE PROXIMAL CONNECTOR. THE HOLE APPEARED TO HAVE BEEN MADE BY A BLUNT OBJECT. THE PRESSURE TEST REVEALED THAT CICUIT #1 WAS WITHIN SPECIFICATION, EXHIBITING NO LEAK, WHILE CIRCUIT #2 WAS OUT OF SPECIFICATION. CONCLUSION: WE ARE UNABLE TO DETERMINE HOW THE EXPIRATORY LIMB FROM CIRCUIT #2 CAME TO BE DAMAGED BUT IT HAD LIKELY OCCURRED POST PRODUCTION. ALL RT340 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 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (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 THAT TWO RT240 BREATHING CIRCUITS FAILED A VENTILATOR LEAK TEST AT THE CONNECTION OF THE Y-PIECE. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT240 BREATHING CIRCUITS FAILED A VENTILATOR LEAK TEST AND THAT THE LEAK CAME FROM THE EXPIRATORY LIMB WHERE IT CONNECTS TO THE Y-PIECE. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT240 120612

    Patients

    Seq Age Sex Outcome Treatment
    1