BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2416875 · Received January 16, 2012

    Report

    Report Number
    9611451-2012-00018
    Event Type
    Malfunction
    Date Received
    January 16, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    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 COMPLAINT RT265 INFANT BREATHING CIRCUITS ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION AS THEY ARE NOT AVAILABLE. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL. IN OUR INVESTIGATION, A PERFORMANCE TEST WAS COMPLETED ON A KNOWN GOOD RT265 CIRCUIT. RESULT: PERFORMANCE TEST REVEALED THAT WHEN THE PORT CAP WAS FULLY INSERTED, THE CIRCUIT PERFORMED WITHIN SPECIFICATION. WHEN THE PORT CAP WAS PARTIALLY INSERTED OR DISCONNECTED (SIMULATING THE REPORTED MISSING PORT CAP), THE CIRCUIT PERFORMED OUTSIDE OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 110825. CONCLUSION: THE PERFORMANCE TEST CONFIRMED THAT THE BREATHING CIRCUIT WOULD FAIL THE PRESSURE TEST IF A PRESSURE PORT CAP IS NOT FULLY INSERTED OR MISSING FROM THE BREATHING CIRCUIT. ALL RT265 BREATHING CIRCUITS ARE PRESSURE AND FLOW TESTED DURING PRODUCTION. IT IS POSSIBLE THAT THE PORT CAP MAY HAVE BEEN DISCONNECTED AFTER THE PRESSURE TEST.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE SALES REPRESENTATIVE THAT THE PORT OF THE EXPIRATORY LIMB OF FOUR RT265 INFANT BREATHING CIRCUIT KITS WAS MISSING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 110825

    Patients

    Seq Age Sex Outcome Treatment
    1