BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3630697 · Received February 17, 2014

    Report

    Report Number
    9611451-2014-00126
    Event Type
    Malfunction
    Date Received
    February 17, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 20, 2014
    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 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR THE REPORTED LEAK. IT WAS SUBSEQUENTLY SUBMERGED IN A WATER BATH TO IDENTIFY THE SOURCE OF THE LEAK. RESULTS: PRESSURE TEST REVEALED THAT THE RETURNED CIRCUIT EXHIBITED LEAK AND WAS OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK WAS FROM THE EXPIRATORY LIMB PROXIMAL CONNECTOR. VISUAL INSPECTION REVEALED INSUFFICIENT GLUE IN THE PROXIMAL CONNECTOR. A LOT CHECK WAS PERFORMED AND NO OTHER COMPLAINTS OF THIS NATURE WERE FOUND FOR LOT 130624. CONCLUSION: ALL RT340 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE THEY ARE RELEASED FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. THE OBSERVED LEAK WAS CAUSED BY INSUFFICIENT GLUE BEING INJECTED INTO THE EVAQUA EXPIRATORY LIMB CONNECTOR SUCH THAT IT DID NOT FORM A PERMANENT SEAL DURING THE ASSEMBLY PROCESS. 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." THE HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUIT BEFORE PATIENT USE WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN RT340 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON A SERVO-I VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100785 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 130624

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR