BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5006497 · Received August 16, 2015

    Report

    Report Number
    9611451-2015-00352
    Event Type
    Malfunction
    Date Received
    August 16, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 14, 2015
    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). PLEASE NOTE THIS REPORT WAS INITIALLY SUBMITTED ON 13 AUGUST 2015. HOWEVER, DUE TO AN ERROR WITH THE FDA GATEWAY IT WAS NOT ACCEPTED. DEVICES RETURNED: DEVICE 1: RT265 LOT 150423; DEVICE 2: RT265 LOT UNKNOWN. METHOD: THE COMPLAINT RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THE RETURNED BREATHING CIRCUITS WERE VISUALLY INSPECTED AND DEVICE 2 WAS PRESSURE TESTED FOR LEAK. RESULTS: VISUAL INSPECTION REVEALED A CRACK ON THE PROXIMAL CONNECTOR OF THE EXPIRATORY LIMB ON BOTH OF THE RETURNED CIRCUITS. THE EXPIRATORY LIMB OF DEVICE 1 WAS DAMAGED APPROXIMATELY 1000MM FROM THE PROXIMAL CONNECTOR AND THE INSPIRATORY LIMB WAS DAMAGED APPROXIMATELY 140MM FROM THE PROXIMAL CONNECTOR. IT WAS NOTED THAT THE PACKAGING OF ALCOHOL SWABS WAS RETURNED WITH DEVICE 1. PRESSURE TEST OF DEVICE 2 SHOWED THAT IT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150423. 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 OBSERVED CRACKING OCCURRED AFTER THE SUBJECT DEVICE WAS RELEASED FOR DISTRIBUTION. OUR 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 TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THEY FOUND A CRACK ON THE CONNECTOR OF TWO RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS AFTER ONE WEEK OF USE ON THE NEWPORT E500 VENTILATOR. ONE WAS FOUND ON (B)(6) 2015 AND THE OTHER WAS FOUND ON (B)(6) 2015. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541163 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 150423

    Patients

    Seq Age Sex Outcome Treatment
    1