BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5707853 · Received June 8, 2016

    Report

    Report Number
    9611451-2016-00245
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    April 30, 2016
    Report Date
    May 10, 2016
    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: ONLY THE EXPIRATORY LIMB OF THE COMPLAINT RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE PROXIMAL CONNECTOR COLLAR ON THE EXPIRATORY LIMB WAS CRACKED; HOWEVER, THERE WAS NO VISIBLE DAMAGE NOTED TO THE TUBING ITSELF. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 160203. CONCLUSION: BASED ON THE NATURE OF THE CRACKING AND PREVIOUS INVESTIGATIONS INTO THIS TYPE OF FAILURE, THE CRACKING IS MOST LIKELY DUE TO THE CONNECTORS COMING INTO CONTACT WITH A CLEANING CHEMICAL, RESULTING IN ENVIRONMENTAL STRESS CRACKING. ALL RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE HOSPITAL REPORTED THAT THE SUBJECT BREATHING CIRCUIT PASSED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE AND THAT THE DAMAGE OCCURRED AFTER THREE DAYS OF USE. THESE SUGGEST THAT THE COMPLAINT BREATHING CIRCUIT BECAME DAMAGED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. 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." THE USER INSTRUCTIONS ALSO STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS OR HAND SANITIZERS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE COLLAR ON THE EXPIRATORY LIMB OF AN RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND CRACKED AFTER THREE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361819 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 160203

    Patients

    Seq Age Sex Outcome Treatment
    1