BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 6593251 · Received May 26, 2017

    Report

    Report Number
    9611451-2017-00470
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Date of Event
    April 27, 2017
    Report Date
    April 27, 2017
    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. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL TO DETERMINE IF THE COMPLAINT BREATHING CIRCUIT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE ARE ALSO ATTEMPTING TO OBTAIN THE SUBJECT COMPLAINT DEVICE FOR FURTHER INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR EVALUATION.

    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 RT268 INFANT EVAQUA2 BREATHING CIRCUIT AND ONE SWIVEL WERE RECEIVED AT (B)(4) FOR EVALUATION. THE SWIVEL Y-PIECE WAS RETURNED DISASSEMBLED FROM THE ELBOW. THE DEVICE WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULT: VISUAL INSPECTION REVEALED THAT ONE OF THE SWIVEL WYE PORTS WAS FOUND CRACKED. THE ELBOW AND SWIVEL WERE RETURNED DISASSEMBLED. THE SWIVEL AND ELBOW WERE ASSEMBLED TOGETHER TO ALLOW THE BREATHING CIRCUIT TO BE PRESSURE TESTED. IT WAS ALSO NOTED THAT ONCE REASSEMBLED THE TWO SWIVEL COMPONENTS FORMED A TIGHT FIT. THE PRESSURE TEST REVEALED THAT THE BREATHING CIRCUIT WAS WITHIN SPECIFICATION AND NOT LEAKING. CONCLUSION: WE WERE UNABLE TO CONFIRM A DISCONNECTION OF THE SWIVEL. INVESTIGATIONS INTO THE CRACKING HAVE DETERMINED THAT THE CRACKING HAS MOST LIKELY OCCURRED DUE TO IMPROPERLY MIXED MATERIAL IN THE BATCH. WE HAVE SINCE CONTACTED THE SUPPLIER AND ARRANGED FOR THEM TO SUPPLY THE MOLDING MATERIAL WITH THE TWO PARTS ALREADY MIXED. WE ANTICIPATE THAT THIS WILL RESOLVE THE ISSUE AND THE PROJECT TO IMPLEMENT THIS CHANGE IS CURRENTLY IN PROCESS. THE INFANT SWIVEL AND ELBOW ARE ASSEMBLED USING A MACHINE TO ENSURE A CONSISTENT TIGHTNESS OF CONNECTION. THE SWIVEL IS THEN PRESSURE AND FLOW TESTED AS PART OF THE INFANT BREATHING CIRCUIT BEFORE LEAVING THE PRODUCTION LINE. ANY BREATHING CIRCUITS THAT FAIL THESE TESTS ARE REJECTED. THE HOSPITAL REPORTED THAT THE DAMAGE OCCURRED AFTER A PERIOD OF USE, WHICH SUGGESTS THAT THE COMPLAINT CIRCUITS BECAME DAMAGED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT266 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 THE (B)(6) REPORTED THAT THE CONNECTION OF THE RT268 INFANT EVAQUA 2 BREATHING CIRCUIT CAME APART DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE CONNECTION OF THE RT268 INFANT EVAQUA 2 BREATHING CIRCUIT CAME APART DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376785 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT268 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1