BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 6796283 · Received August 15, 2017

    Report

    Report Number
    9611451-2017-00751
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Date of Event
    July 17, 2017
    Report Date
    July 19, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). PMA/510(K): THE RT268 INFANT DUAL HEATED 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 SWIVEL WYE OF THE COMPLAINT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH NEW ZEALAND. THE RETURNED SWIVEL WYE WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: VISUAL INSPECTION OF THE RETURNED SWIVEL WYE REVEALED THAT THERE WAS A CRACK ALONG ONE OF THE SWIVEL WYE PORTS. THE PRESSURE TEST RESULT WAS OUTSIDE OF THE SPECIFICATION. CONCLUSION: INVESTIGATIONS INTO THIS ISSUE 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. ALL RT268 INFANT DUAL HEATED EVAQUA2 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 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT 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."

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT268 INFANT DUAL HEATED 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. MANUFACTURER NARRATIVE: WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FROM OUR REGIONAL OFFICE IN (B)(4) FOR INVESTIGATION TO DETERMINE IF IT HAD A MALFUNCTION, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE SWIVEL WYE OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE SWIVEL WYE OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574074 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT268 2100106213

    Patients

    Seq Age Sex Outcome Treatment
    1