BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5784441 · Received July 11, 2016

    Report

    Report Number
    9611451-2016-00330
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 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 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR EVALUATION, WHERE IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION OF THE SUBJECT DEVICE REVEALED A CRACK ON THE EXPIRATORY LIMB PATIENT END CONNECTOR COLLAR. NO VISIBLE DAMAGE WAS OBSERVED ON THE BREATHING CIRCUIT TUBING. THE PRESSURE TEST RESULT WAS OUTSIDE SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 160119. 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 DAMAGE OCCURRED AFTER 6 DAYS OF USE, WHICH SUGGESTS THAT THE COMPLAINT 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 SANITISERS."

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435559 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 2100019372

    Patients

    Seq Age Sex Outcome Treatment
    1