BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED W/ EVAQUA BREATHING CIRCUIT

    MDR report key: 1982826 · Received February 9, 2011

    Report

    Report Number
    9611451-2011-00065
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE RETURNED BREATHING CIRCUIT WAS REPORTED TO HAVE BEEN USED ON AN (B)(6) PATIENT. IT WAS TRIPLE BAGGED FOR RETURN AND IT WAS NOTED THAT SPECIAL CARE MUST BE TAKEN DURING HANDLING DUE TO RISK OF INFECTION. METHOD: THE PACKAGE WHICH CONTAINED THE BREATHING CIRCUIT STILLED CONTAINED FLUIDS; THE PACKAGE WAS NOT OPENED DUE TO RISK OF INFECTION. AN INVESTIGATION WAS CARRIED OUT BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE HOSPITAL REPORTED THAT THE HUMIDIFIER THAT WAS BEING USED WITH THE BREATHING CIRCUIT ALARMED. IT WAS REPORTED THAT THE ALARM WAS RESOLVED BY REPLACING THE BREATHING CIRCUIT. IT WAS ALSO REPORTED THAT WHEN THE COMPLAINT CIRCUIT WAS BEING USED, THE DELIVERED GAS FELT COOL. CONCLUSION: BASED ON THE INFORMATION PROVIDED, IT IS LIKELY THAT THE HEATER WIRE INSIDE OF THE COMPLAINT BREATHING CIRCUIT HAD BECOME OPEN CIRCUIT. THIS WOULD HAVE ALLOWED THE HUMIDIFIED GASES TO COOL SLIGHTLY PRIOR TO DELIVERY AND WOULD HAVE TRIGGERED A HUMIDIFIER ALARM. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME AN OPEN CIRCUIT POST PRODUCTION. OPEN CIRCUIT HEATER WIRES DO NOT PRECLUDE VENTILATION OF THE PATIENT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. (B)(4). RISK OF INFECTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A RESPIRATORY HUMIDIFIER ALARMED DURING USE. IT WAS REPORTED THAT THE HUMIDIFIER, TEMPERATURE PROBE AND HEATER WIRE ADAPTOR WERE CHANGED, BUT THE BREATHING CIRCUIT WAS KEPT. WHEN THE NEW COMPONENTS WERE SET-UP, THE SAME ALARM WAS GENERATED AND THE DELIVERED GAS FELT COOL. THE HOSPITAL THEN CHANGED THE BREATHING CIRCUIT AND THE ALARM WAS RESOLVED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED W/ EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 HEATER WIRE ADAPTOR| FISHER & PAYKEL HEALTHCARE MR850 RESP. HUMIDIFIER| TEMPERATURE/FLOW PROBE