BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3626338 · Received February 13, 2014

    Report

    Report Number
    9611451-2014-00125
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 14, 2014
    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 RT267 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: TWO RT267 INFANT EVAQUA2 BREATHING CIRCUITS INCLUDING THE SWIVEL WYE-PIECE WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR EVALUATION. THEY WERE VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK ON THE SWIVEL WYE PIECE ON BOTH OF THE CIRCUITS. FURTHERMORE, ONE OF THE SWIVEL WYE PIECES WAS NOT PROPERLY SEATED IN THE ELBOW. PRESSURE TEST REVEALED THAT THIS SWIVEL WYE PIECE EXHIBITED LEAK AND WAS OUT OF SPECIFICATION. THE OTHER SWIVEL WYE WAS WITHIN SPECIFICATION. UPON CORRECTLY FITTING THE SWIVEL WYE PIECE INTO THE ELBOW THE SWIVEL WYE WAS PRESSURE TESTED AGAIN AND WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 121005. CONCLUSION: THE RETURNED SWIVEL WYE PIECES WERE MOST LIKELY SUBJECTED TO PHYSICAL FORCE SUFFICIENT TO CRACK AND PARTIALLY DISLODGE THE SWIVEL WYE FROM THE ELBOW. THIS MAY HAVE OCCURRED DURING TRANSPORT, WHILE OPENING THE PACKAGING, OR APPLYING EXCESSIVE FORCE WHILE CONNECTING OR DISCONNECTING THE BREATHING CIRCUIT CONNECTORS. ALL BREATHING CIRCUITS ARE PRESSURE TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION AND ANY CIRCUITS THAT FAIL ARE REJECTED. ANY LEAKS IN THE BREATHING CIRCUIT INCLUDING THE SWIVEL WYE WOULD HAVE BEEN IDENTIFIED DURING THIS TESTING. THIS SUGGESTS THAT THE RETURNED SWIVEL WYE WAS WITHIN SPECIFICATION WHEN RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT267 INFANT EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE"

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT SWIVEL WYE-PIECE WAS CRACKED ON TWO RT267 INFANT EVAQUA2 BREATHING CIRCUITS. THESE WERE FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96392 INFANT EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT267 121005

    Patients

    Seq Age Sex Outcome Treatment
    1