BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5186279 · Received October 28, 2015

    Report

    Report Number
    9611451-2015-00451
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 2, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THREE UNSEALED RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. TWO OF THE SUBJECT BREATHING CIRCUITS (DEVICES 1 AND 2) WERE RETURNED WITHOUT SWIVEL WYES AND LOT INFORMATION. THE THIRD BREATHING CIRCUIT (DEVICE 3) HAS LOT NUMBER 150625. ALL BREATHING CIRCUITS WERE VISUALLY INSPECTED; HOWEVER, ONLY DEVICE 3 WAS PRESSURE TESTED AS THE SWIVEL WYES OF DEVICES 1 AND 2 WERE NOT RETURNED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO ALL THREE RETURNED RT265 INFANT BREATHING CIRCUITS. THE PRESSURE LINES OF DEVICES 1 AND 2 WERE FOUND TO BE PARTLY INSERTED AND TAPED INTO THE PRESSURE LINE PORTS. A TIGHT FIT WAS FORMED WHEN THE PRESSURE LINES WERE FULLY INSERTED INTO THE PRESSURE LINE PORTS. THE PRESSURE LINE OF DEVICE 3 WAS FOUND TO BE FULLY INSERTED AND FORMED A TIGHT FIT WITH THE PRESSURE LINE PORT. THE PRESSURE TEST RESULT OF DEVICE 3 WAS WITHIN SPECIFICATION. NO DISCONNECTION WAS OBSERVED BETWEEN THE LIMBS AND THE SWIVEL WYE DURING PRESSURE TEST. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150625. CONCLUSION: NO FAULT WAS FOUND TO THE RETURNED BREATHING CIRCUITS AS THE DISCONNECTION REPORTED BY THE HEALTHCARE FACILITY WAS NOT REPLICATED DURING INSPECTION. THE REPORTED PROBLEM APPEARS TO HAVE BEEN CAUSED BY THE PRESSURE LINE BEING ACCIDENTALLY PULLED AWAY DURING USE. ALL RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED, AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND 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 HEALTHCARE FACILITY IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE CONNECTOR ON AN RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS DISCONNECTING TOO EASILY FROM THE Y-PIECE DURING USE, CAUSING THE PRESSURE LINE TO DROP. THIS WAS ALSO OBSERVED ON TWO OTHER UNITS OF RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713460 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 150625

    Patients

    Seq Age Sex Outcome Treatment
    1