BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5199349 · Received November 3, 2015

    Report

    Report Number
    9611451-2015-00458
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Report Date
    October 5, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: ONLY THE SWIVEL OF THE COMPLAINT RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INVESTIGATION. IT WAS VISUALLY INSPECTED FOR THE REPORTED FAULT. PRESSURE TEST WAS NOT CONDUCTED AS THE OTHER PARTS OF THE SUBJECT BREATHING CIRCUIT WERE NOT RECEIVED. RESULTS: VISUAL INSPECTION REVEALED A CRACK ALONG THE WELD LINE AND DAMAGE AT THE EDGE OF THE SWIVEL WYE PORT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150623. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAULT REPORTED BY THE HOSPITAL AS ONLY THE SWIVEL OF THE COMPLAINT RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO US FOR INSPECTION. ALL INFANT EVAQUA BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND USE OF THE BREATHING CIRCUIT KIT. IT ALSO STATES 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 Y-PIECE OF AN RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT HAD CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729333 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT266 150623

    Patients

    Seq Age Sex Outcome Treatment
    1