BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3447603 · Received November 4, 2013

    Report

    Report Number
    9611451-2013-00873
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THEY WERE PRESSURE TESTED, VISUALLY INSPECTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULTS WERE OUT OF SPECIFICATION DUE TO LEAKAGE COMING FROM THE PATIENT END CONNECTORS. THIS WAS CONFIRMED WHEN THE SUBJECT BREATHING CIRCUITS WERE IMMERSED IN THE WATER BATH. VISUAL INSPECTION REVEALED THAT THERE WAS NOT ENOUGH GLUE PRESENT IN THE EVAQUA EXPIRATORY LIMB CONNECTOR OF EACH BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130719. 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. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "VERIFY THAT VENTILATOR ALARMS ARE SET TO DETECT LOSS OF PRESSURE AND OVER PRESSURE." THE HOSPITAL STAFF CORRECTLY CHECKED THE SUBJECT BREATHING CIRCUITS BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR RT240 USER INSTRUCTIONS. 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 MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF OCTOBER 2013.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED THAT TWO RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FAILED THE INITIAL LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FAILED THE INITIAL LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566317 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT240 130719

    Patients

    Seq Age Sex Outcome Treatment
    1