BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1981992 · Received February 8, 2011

    Report

    Report Number
    9611451-2011-00052
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 11, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RT200 ADULT DUAL-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT200 ADULT BREATHING CIRCUITS, WITH LOT NUMBER 100916, HAD BEEN USED BY SWINE FLU PATIENTS AND WERE NOT RETURNED TO FPH (B)(4) FOR INVESTIGATION. THE HOSPITAL RETURNED 10 OTHER RT200 ADULT BREATHING CIRCUITS FROM THE SAME LOT FOR FURTHER INVESTIGATION. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN THE INSPIRATORY AND THE EXPIRATORY TUBES OF THE RETURNED BREATHING CIRCUITS WERE TESTED USING A MULTIMETER. A CONTINUITY TEST WAS USED TO CHECK FOR ANY BREAKS IN THE HEATER WIRES. RESULTS: NO FAULT WAS FOUND WITH THE RETURNED BREATHING CIRCUITS. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN THE INSPIRATORY AND THE EXPIRATORY TUBES WERE WITHIN SPECIFICATIONS. BASED ON THE RESULTS OF OUR PREVIOUS INVESTIGATION OF SIMILAR COMPLAINTS, THE REPORTED ALARM ON THE HUMIDIFIER WAS MOST LIKELY DUE TO AN OPEN CIRCUIT HEATER WIRE, CAUSED BY A BREAK IN CONNECTION BETWEEN THE HEATER WIRE AND ONE OF THE PINS THAT CRIMPS TO THE HEATER WIRE. A LOT CHECK REVEALED 4 OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100916. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THE FOLLOWING TO (B)(4) INVOLVING AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT: "CONTINUOUSLY ALARMING HUMIDIFIER. HUMIDIFIER CHANGED X3. WIRES CHANGED. BOTH SENT TO (B)(4) TO BE CHECKED FOR FUNCTIONALITY. BOTH FINE. THIRD REPORT OF FAULTY HUMIDIFIER OR WIRES IN ONE WEEK. ALL CHANGED, SAME ALARM OCCURRING. LOOKED BACK AND SAME BATCH 100916 OF CIRCUITS USED IN EACH INSTANCE. UNSURE OF FAULT. DRYING OF THE MUCOSA, DRYING OF SECRETIONS, POSSIBILITY OF OCCLUDING AIRWAY DUE TO INEFFICIENT HUMIDIFICATION. WHOLE BATCH REMOVED AND REPLACED WITH ALTERNATIVE BATCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT200 100916

    Patients

    Seq Age Sex Outcome Treatment
    1