BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2914476 · Received January 14, 2013

    Report

    Report Number
    9611451-2013-00041
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    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 VISUALLY INSPECTED, PRESSURE TESTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS NOT ENOUGH GLUE PRESENT IN THE PROXIMAL CONNECTOR. PRESSURE TEST RESULT SHOWED THAT THE BREATHING CIRCUIT WAS OUT OF SPECIFICATION DUE TO LEAKAGE COMING FROM THE PATIENT END CONNECTOR. THIS WAS CONFIRMED WHEN THE BREATHING CIRCUIT WAS IMMERSED IN A WATER BATH. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120808. CONCLUSION: THE OBSERVED LEAK WAS CAUSED BY INSUFFICIENT GLUE BEING INJECTED INTO THE EVAQUA LIMB CONNECTOR DURING THE ASSEMBLY PROCESS, AND THIS WAS NOT PICKED UP DURING THE PRESSURE TEST. 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." "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS 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 AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. 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 AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19869 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 120808

    Patients

    Seq Age Sex Outcome Treatment
    1