BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5579698 · Received April 14, 2016

    Report

    Report Number
    9611451-2016-00149
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 16, 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 CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THE RETURNED BREATHING CIRCUITS WERE VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED THAT ONE RETURNED CIRCUIT (LOT 150914, MANUFACTURED ON 14 SEPTEMBER 2015) HAD THE PROXIMAL CONNECTOR OF THE EXPIRATORY LIMB CRACKED. THE OTHER RETURNED CIRCUIT (LOT 150807, MANUFACTURED ON 7 AUGUST 2015) HAD BOTH THE PROXIMAL AND DISTAL CONNECTOR OF THE EXPIRATORY LIMB CRACKED. NO OTHER DAMAGE WAS OBSERVED TO THE BREATHING CIRCUIT. THE PRESSURE TEST SHOWED THAT THE RETURNED BREATHING CIRCUITS WERE OUTSIDE SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150807 AND LOT NUMBER 150914. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE NOTED ON THE RETURNED BREATHING CIRCUITS. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS SUGGEST THAT THE OBSERVED CRACKING ON THE CONNECTORS 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. THIS SUGGESTS THAT THE COMPLAINT CIRCUITS BECAME DAMAGED AFTER THEY WERE 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 RESUE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS OR HAND SANITISERS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THEY HAD TWO INCIDENTS WHERE THEY FOUND A CRACK ON THE COLLAR ON THE EXPIRATORY LIMB OF TWO RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS. ONE WAS FOUND ON (B)(6) 2016 AFTER FIVE DAYS OF USE, ANOTHER WAS FOUND ON (B)(6) 2016 AFTER FOUR DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232664 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 150807

    Patients

    Seq Age Sex Outcome Treatment
    1