BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4924104 · Received July 19, 2015

    Report

    Report Number
    9611451-2015-00318
    Event Type
    Malfunction
    Date Received
    July 19, 2015
    Report Date
    June 22, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE MFR DATE: (B)(6) (B)(6) 2014 (B)(6) (B)(6) 2015 (B)(6) (B)(6) 2015 METHOD: EIGHT OF THE NINE COMPLAINT (B)(4) INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE RETURNED TO FPH IN (B)(6) AND WERE PRESSURE TESTED FOR LEAKS. THE UNIT WITHOUT LOT NUMBER, AS SPECIFIED ABOVE, WAS NOT RETURNED TO FPH FOR INSPECTION. AN ATTEMPT WAS ALSO MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT BUT NO RESPONSE WAS RECEIVED FROM THE HEALTHCARE FACILITY. RESULTS: NO FAULT WAS FOUND WITH THE RETURNED (B)(4) INFANT BREATHING CIRCUITS DURING PRESSURE TEST. THE TEST RESULTS WERE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 141022, 150113, 150129 AND 150211. CONCLUSION: THE LEAK REPORTED BY THE HEALTHCARE FACILITY WAS NOT REPLICATED DURING INSPECTION. WE ARE THEREFORE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED PROBLEM. ALL RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED PRIOR TO DISTRIBUTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT RT266 INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THIS SUGGESTS THE LEAK OCCURRED POST PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT266 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."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT NINE RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE FOUND LEAKING AROUND THE PRESSURE PORT DUE TO "IMPROPER ATTACHMENT". THIS WAS OBSERVED DURING USE ON PATIENTS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467946 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT266 SEE H10 MANUFACTURER NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1