BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 6723838 · Received July 18, 2017

    Report

    Report Number
    9611451-2017-00651
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 23, 2017
    Report Date
    June 23, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). 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 COMPLAINT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH (B)(6) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED A CRACK ALONG ONE OF THE SWIVEL WYE PORTS. FURTHER DAMAGE WAS ALSO OBSERVED AROUND THE CRACKED AREA. 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 SCHEDULED NEXT MONTH. 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 THE HOSPITAL 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 THAT THE SWIVEL CONNECTOR OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS CRACKING AND FALLING APART. THIS WAS OBSERVED DURING USE ON A PATIENT. IT WAS ALSO REPORTED THAT THE CRACK CAUSED A BIG LEAK ON THE VENTILATOR, AFFECTING THE PRESSURE DELIVERY. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE SWIVEL CONNECTOR OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS CRACKING AND FALLING APART. THIS WAS OBSERVED DURING USE ON A PATIENT. IT WAS ALSO REPORTED THAT THE CRACK CAUSED A BIG LEAK ON THE VENTILATOR, AFFECTING THE PRESSURE DELIVERY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502426 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT268 NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1