BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2988434 · Received March 4, 2013

    Report

    Report Number
    9611451-2013-00153
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Report Date
    February 6, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO EXPIRATORY EVAQUA LIMBS, AND FOUR UNSEALED BUT UNUSED RT340 ADULT BREATHING CIRCUIT KITS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE EXPIRATORY EVAQUA LIMBS WERE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: NO FAULT WAS FOUND WITH THE EXPIRATORY EVAQUA LIMBS THAT WERE INCLUDED IN THE UNSEALED KITS. THE PRESSURE TEST RESULTS WERE WITHIN SPECIFICATION. THE OTHER TWO EXPIRATORY LIMBS FAILED THE PRESSURE TEST DUE TO LEAKAGE FROM THE PATIENT END CONNECTOR. THE LEAK WAS CONFIRMED WHEN EACH LIMB WAS IMMERSED IN A WATER BATH. FURTHER INSPECTION REVEALED THAT THERE WAS INSUFFICIENT GLUE PRESENT IN THE PROXIMAL CONNECTOR OF EACH EXPIRATORY LIMB. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120829. CONCLUSION: THE OBSERVED LEAK WAS CAUSED BY INSUFFICIENT GLUE BEING INJECTED INTO THE EVAQUA LIMB CONNECTOR DURING THE ASSEMBLY PROCESS, WHICH WAS NOT PICKED UP DURING PRESSURE TESTING IN THE PRODUCTION LINE. 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." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT SOME RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST DUE TO A HOLE AT THE END OF THE EXPIRATORY LIMBS. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT SOME RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91313 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 120829

    Patients

    Seq Age Sex Outcome Treatment
    1