BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3598526 · Received January 29, 2014

    Report

    Report Number
    9611451-2014-00085
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 10, 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 FPH IN (B)(4) FOR INSPECTION. IT WAS PRESSURE TESTED, VISUALLY INSPECTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULT WAS OUT OF SPECIFICATION DUE TO EXCESSIVE LEAKAGE COMING FROM THE PATIENT END CONNECTOR. THIS WAS CONFIRMED WHEN THE SUBJECT BREATHING CIRCUIT WAS IMMERSED IN THE WATER BATH. VISUAL INSPECTION REVEALED THAT THERE WAS NOT ENOUGH GLUE PRESENT IN THE EVAQUA EXPIRATORY LIMB CONNECTOR, CAUSING THE REPORTED LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130924. CONCLUSION: ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE RELEASING FOR DISTRIBUTION, AND THOSE THAT FAIL ARE REJECTED. 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 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". OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING INCORRECTLY ASSEMBLED ADULT EVAQUA BREATHING CIRCUITS DUE TO INSUFFICIENT GLUE APPLIED HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER (B)(4) SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF DECEMBER 2013.

    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 VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63216 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 130924

    Patients

    Seq Age Sex Outcome Treatment
    1