BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5236557 · Received November 19, 2015

    Report

    Report Number
    9611451-2015-00488
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 20, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT PRESSURE LINES WERE RETURNED TO (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED PRESSURE LINES. THE PRESSURE LINE ADAPTORS WERE FULLY ATTACHED TO THE RETURNED PRESSURE LINES. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150113. CONCLUSION: WE ARE UNABLE TO DETERMINE HOW THE PRESSURE LINE ADAPTORS BECAME DISCONNECTED FROM THE PRESSURE LINES. AN ATTEMPT TO DISCONNECT A PRESSURE LINE ADAPTOR FROM A PRESSURE LINE BY HAND WOULD REQUIRE A SIGNIFICANT AMOUNT OF FORCE. EACH PRESSURE LINE OF RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT IS VISUALLY INSPECTED BEFORE LEAVING THE PRODUCTION LINE, ENSURING THAT THE PRESSURE LINE ADAPTOR IS FULLY INSERTED INTO THE PRESSURE LINE. THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 INFANT DUAL HEATED EVAQUA2 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". "SET APPROPRIATE VENTILATOR ALARMS".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE PRESSURE LINE ADAPTOR WAS DISCONNECTING FROM THE PRESSURE LINE, WHICH IS PART OF THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT KIT. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764990 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 150113

    Patients

    Seq Age Sex Outcome Treatment
    1