BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3441360 · Received October 31, 2013

    Report

    Report Number
    9611451-2013-00865
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    September 25, 2013
    Report Date
    October 4, 2013
    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 BREATHING CIRCUIT WAS PRESSURE TESTED, VISUALLY INSPECTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST REVEALED THAT THE EXPIRATORY LIMB WAS OUT OF SPECIFICATION DUE TO LEAKAGE FROM THE PATIENT END CONNECTOR. THIS WAS CONFIRMED WHEN THE BREATHING CIRCUIT WAS IMMERSED IN THE WATER BATH. VISUAL INSPECTION REVEALED THAT THERE WAS GLUE PRESENT IN THE EVAQUA LIMB CONNECTOR. HOWEVER, IT WAS OBSERVED THAT THE GLUE DID NOT FORM A PERMANENT SEAL DURING THE ASSEMBLY PROCESS, CAUSING THE REPORTED LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF A SIMILAR NATURE FOR LOT DATE 130703. CONCLUSION: 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. THIS SUGGESTS THAT ANY LEAK MUST HAVE DEVELOPED AFTER THE BREATHING CIRCUIT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 ADULT DUAL-HEATED EVAQUA 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." THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE LEAK DURING THE SETUP CHECK AND BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE LEAK TEST ON A PB840 VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559830 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 130703

    Patients

    Seq Age Sex Outcome Treatment
    1 PB840 VENTILATOR