BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3936302 · Received July 15, 2014

    Report

    Report Number
    9611451-2014-00617
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 28, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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) FOR EVALUATION. THE CIRCUIT WAS VISUALLY INSPECTED, PRESSURE TESTED AND IMMERSED IN A WATER BATH TO CHECK FOR LEAK. RESULTS: THE PRESSURE TEST RESULT REVEALED THAT THE CIRCUIT WAS OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK WAS THROUGH THE ELBOW CONNECTOR ON THE EXPIRATORY (EVAQUA) LIMB. VISUAL INSPECTION REVEALED THAT THERE WAS NOT ENOUGH GLUE PRESENT IN THE EVAQUA LIMB CONNECTOR, CAUSING THE REPORTED LEAK. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSION: THE OBSERVED LEAK WAS CAUSED BY INSUFFICIENT GLUE BEING INJECTED INTO THE EVAQUA LIMB CONNECTOR SUCH THAT IT DID NOT FORM A PERMANENT SEAL AFTER RELEASE FOR DISTRIBUTION. 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. THE USER INSTRUCTIONS THAT ACCOMPANY 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." THE HOSPITAL STAFF CORRECTLY CHECKED THE RT340 BREATHING CIRCUIT FOR LEAK 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 FIELD REPRESENTATIVE THAT AN RT340 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON A SERVO-I VENTILATOR. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR