BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5652437 · Received May 13, 2016

    Report

    Report Number
    9611451-2016-00208
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 13, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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: THE COMPLAINT RT265 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THE RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE PROXIMAL CONNECTOR OF THE EXPIRATORY LIMB CRACKED. NO OTHER DAMAGE WAS OBSERVED TO THE BREATHING CIRCUIT. THE PRESSURE TEST SHOWED THAT THE RETURNED BREATHING CIRCUIT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED THREE OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150914. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE NOTED ON THE RETURNED BREATHING CIRCUIT. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS SUGGEST THAT THE OBSERVED CRACKING ON THE CONNECTOR WAS MOST LIKELY DUE TO THE CONNECTOR COMING INTO CONTACT WITH CLEANING CHEMICALS 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 DAMAGE OCCURRED AFTER THREE DAYS OF USE, WHICH SUGGESTS THAT THE COMPLAINT CIRCUIT BECAME DAMAGED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT265 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 VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THEY FOUND A CRACK ON THE COLLAR ON THE EXPIRATORY LIMB OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT. THIS WAS FOUND AFTER THREE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309492 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 150914

    Patients

    Seq Age Sex Outcome Treatment
    1