BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2843193 · Received November 21, 2012

    Report

    Report Number
    9611451-2012-00843
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR THE REPORTED LEAK. THE RETURNED BREATHING CIRCUIT WAS SUBSEQUENTLY SUBMERGED IN A WATER BATH TO IDENTIFY THE SOURCE OF THE LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT THE RETURNED BREATHING CIRCUIT WAS OUT OF SPECIFICATION DUE TO EXCESSIVE LEAK. VISUAL INSPECTION IDENTIFIED THAT INSUFFICIENT GLUE WAS PRESENT AROUND PROXIMAL TUBING CONNECTION OF THE EXPIRATORY LIMB. THE WATER BATH TEST HIGHLIGHTED THAT THIS WAS THE SOURCE OF THE REPORTED LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120531. CONCLUSION: THE BREATHING CIRCUIT EXHIBITED SOME LEAKS DUE TO INSUFFICIENT GLUE AROUND THE PROXIMAL TUBING CONNECTION. ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE. ANY BREATHING CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE PROXIMAL CONNECTOR ONLY STARTED TO LEAK ONCE IT WAS SET UP FOR USE. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEATLHCARE REPRESENTATIVE THAT WATER WAS LEAKING FROM THE PROXIMAL CONNECTOR ON THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THIS WAS REPORTED AFTER SIX DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    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 120531

    Patients

    Seq Age Sex Outcome Treatment
    1