BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4800654 · Received May 28, 2015

    Report

    Report Number
    9611451-2015-00259
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 30, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE RT268 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 K103767 METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE AND WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK IN THE YELLOW SLE RESTRICTOR, ALONG THE WELD LINE FROM THE FEMALE END OF THE CONNECTOR. THE PRESSURE TEST REVEALED THAT THE CIRCUIT WAS WITHIN SPECIFICATION AND DID NOT EXHIBIT SIGNIFICANT LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 141217. WE HAVE ONLY RECEIVED ONE OTHER COMPLAINT OF THIS NATURE FOR THE RT268 BREATHING CIRCUIT. CONCLUSION: THE CRACK ALONG THE FLOW LINE COULD HAVE MADE IT WEAKER THAN USUAL, AND IT THUS CRACKED WHEN THE USER TIGHTENED THE CONNECTORS DURING SET UP. THIS WAS LIKELY CAUSED BY A MOLDING DEFECT IN THE RESTRICTOR. ALL INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 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 THEY FOUND A CRACK IN THE RESTRICTOR OF AN RT268 INFANT EVAQUA 2 BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347169 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT268 141217

    Patients

    Seq Age Sex Outcome Treatment
    1