BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2540235 · Received April 18, 2012

    Report

    Report Number
    9611451-2012-00224
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K100554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING COMPONENTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION: -FISHER & PAYKEL HEALTHCARE RT241 ADULT HEATED BREATHING CIRCUIT -FISHER & PAYKEL HEALTHCARE MR290V AUTOFEED HUMIDIFICATION CHAMBER (LOT 110216, DATE OF MANUFACTURE FEBRUARY 16, 2011); -FISHER & PAYKEL HEALTHCARE OPT846 OPTIFLOW NASAL CANNULA; -FISHER & PAYKEL HEALTHCARE MR880 HUMIDIFIER. METHOD: THE HOSPITAL REPORTED THAT A WATER BAG THAT WAS ON A SETUP WHICH INCLUDED THE RT241 BREATHING CIRCUIT INFLATED. IN ORDER FOR A WATER BAG TO INFLATE, THERE MUST BE AN OCCLUSION IN THE SYSTEM WHICH DIVERTS THE FLOW FROM THE PATIENT TO THE WATER BAG. FOR THIS REASON, THE RETURNED RT241 BREATHING CIRCUIT AND ASSOCIATED COMPONENTS WERE VISUALLY INSPECTED FOR OCCLUSIONS. RESULTS: NO OCCLUSIONS OR OTHER DAMAGE WAS FOUND IN THE RT241 BREATHING CIRCUIT OR OTHER RETURNED COMPONENTS. CONCLUSION: NO FAULT WAS FOUND WITH THE COMPLAINT DEVICES AS THE RT241 BREATHING CIRCUIT AND OTHER RETURNED COMPONENTS SHOWED NO SIGNS OF OCCLUSION OR DAMAGE. WHEN APPRACHED FOR FURTHER INFORMATION REGARDING THIS INCIDENT, THE HOSPITAL INFORMED US THAT THE BREATHING CIRCUIT WAS PLACED UNDER THE PATIENT'S PILLOW, DUE TO THE MR880 BEING PLACED BEHIND THE BED SPACE. IN ADDITION, THE PATIENT STATED THAT HE WAS "HOLDING HIS NOSE FOR SHORT PERIODS DUE TO THE FACT THAT HE SAID HIS EARS WERE UNDER PRESSURE AND NEEDED TO BE POPPED (LIKE LANDING IN AN AEROPLANE)". ANOTHER FACTOR IS THAT THE HOSPITAL HAS STATED THEY WERE USING THE OPTIFLOW SYSTEM WITH FLOWS OF 55 TO 60 L/MIN. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPTIFLOW NASAL CANNULA STATE: "FLOW RANGE: 5 -45 L/MIN." IT IS MOST LIKELY THEREFORE THAT THE EXCESSIVE FLOW OF 55-60 L/MIN IN CONJUNCTION WITH THE PLACEMENT OF THE TUBING (UNDER THE PATIENT'S PILLOW) RESULTED IN ENOUGH BACK PRESSURE TO INFLATE THE WATERBAG. WHEN THE SYSTEM WAS REPLACED, A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE WAS PRESENT TO SET THE SYSTEM UP CORRECTLY, WHICH MOST LIKELY EXPLAINS WHY THE REPLACEMENT SYSTEM FUNCTIONED NORMALLY. ALL CIRCUITS AND HUMIDIFICATION CHAMBERS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE AND ANY DEVICES THAT FAIL ARE REJECTED. THIS SUGGESTS THAT ANY OCCLUSION THAT MAY HAVE CAUSED THE WATER BAG TO INFLATE DEVELOPED POST-PRODUCTION. THE RT241 CIRCUIT KIT USER INSTRUCTIONS STATE THE FOLLOWING: -BEFORE CONNECTING TO A PATIENT, CHECK FOR ADEQUATE GAS FLOW.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT DURING USE OF AN RT241 ADULT HEATED BREATHING CIRCUIT AND AN OPTIFLOW NASAL CANNULA WITH A FLOW SETTING OF 55 TO 60 LPM, THE CRITICAL CARE TECHNICIAN NOTICED THAT THE BAG HAD SLOWLY INFLATED AFTER THE SYSTEM WAS REPLACED WITH A NEW ONE EVERYTHING FUNCTIONED NORMALLY. STAFF COMMENTED THAT THEY DID NOT KNOW WHERE THE OCCLUSION HAD OCCURRED TO PRODUCE THE PRESSURE THAT INFLATED THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT241 110217

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL MR290V HUMIDIFICATION CHAMBER| FISHER & PAYKEL MR880 HUMIDIFIER| FISHER & PAYKEL OPT846 NASAL CANNULA