BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4153298 · Received October 8, 2014

    Report

    Report Number
    9611451-2014-00800
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY LIMB OF THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR EVALUATION. THE RETURNED INSPIRATORY LIMB WAS VISUALLY INSPECTED AND A HEATER WIRE RESISTANCE TEST WAS CARRIED OUT USING A CALIBRATED MULTIMETER. RESULTS: THE RESISTANCE TEST REVEALED THAT THE INSPIRATORY HEATER WIRE WAS OUT OF SPECIFICATION. CONTINUITY TESTING AND VISUAL INSPECTION REVEALED THAT THE OPEN CIRCUIT IN THE INSPIRATORY HEATER WIRE WAS DUE TO A BREAK IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE LEFT HEATER WIRE PIN INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT DATE 140528. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION, RENDERING THE CIRCUIT UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION. ANY CIRCUIT THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE HEATER WIRE BECAME OPEN CIRCUIT AFTER IT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "SET APPROPRIATE VENTILATOR ALARMS". OUR MONITORING AND TRENDING OF ELECTRICAL OPEN CIRCUITS IN HEATER WIRES IN ADULT BREATHING CIRCUITS HAS A RATE OF 12 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF (B)(6) 2014.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT CAUSED THE HUMIDIFIER TO ALARM DURING SETUP. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630412 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT380 140528

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL MR850 HUMIDIFIER