BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 3828405 · Received May 22, 2014

    Report

    Report Number
    9611451-2014-00464
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 25, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE INSPIRATORY AND EXPIRATORY HEATER WIRES OF THE TWO COMPLAINT DEVICES WERE RESISTANCE TESTED USING A CALIBRATED MULTIMETER. RESULTS: VISUAL INSPECTION REVEALED THAT NO DAMAGE WAS OBSERVED TO THE COMPLAINT DEVICES. ELECTRICAL RESISTANCE TESTING WAS CARRIED OUT ON EACH COMPLAINT DEVICE. THE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE RESISTANCE OF BOTH COMPLAINT DEVICES WAS OPEN CIRCUIT. CONTINUITY TESTING SHOWED THAT THE OPEN CIRCUIT WAS LOCATED IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE LEFT HEATER WIRE PIN INSIDE THE OVERMOULDED PLUG FOR DEVICE 1. FOR DEVICE 2 THE OPEN CIRCUIT WAS LOCATED IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE RIGHT HEATER WIRE PIN INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130814. 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 RT329 INFANT CONTINUOUS FLOW 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 COMPLAINTS INVOLVING ELECTRICAL OPEN CIRCUITS IN HEATER WIRES IN INFANT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT TWO RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUITS WOULD NOT HEAT. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT TWO RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUITS WOULD NOT HEAT. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305327 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT329 130814

    Patients

    Seq Age Sex Outcome Treatment
    1