BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3417516 · Received October 17, 2013

    Report

    Report Number
    9611451-2013-00819
    Event Type
    Malfunction
    Date Received
    October 17, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 18, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. METHOD: THE THREE COMPLAINT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE. ONE CIRCUIT WAS FROM LOT 130318. LOT NUMBERS WERE NOT PROVIDED FOR THE OTHER TWO CIRCUITS. ALL THREE CIRCUITS WERE VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE STRAIGHT CONNECTOR ON THE EXPIRATORY LIMB WAS CRACKED IN ALL THREE OF THE RETURNED CIRCUITS. ADDITIONALLY TWO OF THE THREE CIRCUITS FAILED THE PRESSURE TEST, AS THE AMOUNT OF LEAK GENERATED WAS OUTSIDE THE SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 130318. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE CONNECTORS TO CRACK. ALL INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE HOSPITAL REPORTED THAT THE EACH OF THE SUBJECT BREATHING CIRCUITS WERE USED FOR FIVE DAYS PRIOR TO THE OBSERVED CRACKING. THIS SUGGESTS THAT THE COMPLAINT CIRCUITS WERE WITHIN SPECIFICATION PRIOR TO BEING 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT PATIENT END CONNECTORS OF THREE RT265 INFANT EVAQUA 2 BREATHING CIRCUITS WERE FOUND TO BE CRACKED AFTER FIVE DAYS OF USE WITH A NEWPORT E360 VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533348 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 130318

    Patients

    Seq Age Sex Outcome Treatment
    1 NEWPORT E360 VENTILATOR