BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4636951 · Received March 26, 2015

    Report

    Report Number
    9611451-2015-00173
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Report Date
    March 2, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICE FOR EVALUATION. OUR INVESTIGATION IS IN PROGRESS AND WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FOUR RT266 INFANT BREATHING CIRCUITS (1X LOT 141023, MANUFACTURED ON 23 OCTOBER 2014; 1X LOT 141201, MANUFACTURED ON 1 DECEMBER 2014; 2X LOT 150203, MANUFACTURED ON 3 FEBRUARY 2015), THREE DRYLINES AND TWO SWIVELS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR FURTHER INVESTIGATION. THE DEVICES WERE VISUALLY INSPECTED, THE CIRCUITS AND SWIVELS WERE ADDITIONALLY PRESSURE TESTED AND THE DRYLINES WERE ADDITIONALLY WATER BATH TESTED TO CHECK FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE RETURNED CIRCUITS AND SWIVELS. THE PRESSURE TEST RESULT REVEALED THAT THE CIRCUITS AND RETURNED SWIVELS WERE WITHIN SPECIFICATION. VISUAL INSPECTION OF THE THREE RETURNED DRYLINES REVEALED THAT IN ALL THREE CASES THE FIRST TUBE CORRUGATION FROM THE CHAMBER END WAS DAMAGED AND APPEARED TO HAVE BEEN COMPRESSED AND PINCHED. THERE WAS A PIN-SIZED HOLE NEXT TO THE COMPRESSED PART OF THE CORRUGATION. ADDITIONALLY, TWO OF THE THREE DRYLINES HAD STRESS MARKS ON THE CHAMBER END TUBE COLLAR. THE WATER BATH TEST SHOWED THAT ALL THREE DRYLINES WERE LEAKING FROM THE PIN-SIZED HOLE IN THE DRYLINE TUBING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 141023, LOT 141201 OR LOT 150203. CONCLUSION: WE ARE UNABLE TO DETERMINE WHY THE SWIVEL WYE OF AN RT266 CIRCUIT WAS "DISCONNECTING AND THE CAP POPPING OFF." ALL SWIVELS WERE CHECKED FOR TIGHTNESS OF FIT DURING THE PRESSURE TESTING AND NO DISCONNECTION OCCURED. WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PINCHING OF THE RETURNED DRYLINES. NO FAULT WAS FOUND WITH THE RETURNED RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS AND SWIVELS. ALL RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE 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 (B)(6) , REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE SWIVEL WYE OF AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT "IS DISCONNECTING AND THE CAP IS POPPING OFF." NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE SWIVEL WYE OF AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT "IS DISCONNECTING AND THE CAP IS POPPING OFF." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203179 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT266 141023

    Patients

    Seq Age Sex Outcome Treatment
    1