BEUDAMED
    FDA Adverse Event Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 2190021 · Received August 4, 2011

    Report

    Report Number
    9611451-2011-00472
    Date Received
    August 4, 2011
    Report Date
    July 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS ANTICIPATED. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THE COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT846 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. THE OPT846 CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE WHICH IS CONNECTED TO A RIGID PLASTIC BASE AND SOFT NASAL PRONGS (NASAL INTERFACE). THE INTERFACE IS HELD IN PLACE BY A HEAD STRAP AND ALSO INCLUDES A LANYARD WHICH IS PLACED AROUND THE PATIENT'S NECK OR ATTACHED TO THE PATIENT'S CLOTHING OR BEDDING TO REMOVE THE LOAD OF THE BREATHING CIRCUIT FROM THE PATIENT'S NARES. IN THIS CASE, THE HOSPITAL HAS SET UP AN OPT846 CANNULA WITH A SETUP FOR WHICH IT IS NOT DESIGNED, IE THEY HAVE USED A STANDARD HIGH FLOW SYSTEM WHICH REQUIRES AN INTERFACE WITH A SHORTER EXTENSION, SUCH AS THE FISHER & PAYKEL HEALTHCARE (FPH) OPT546 CANNULA. THE OPT846 HAS A 320MM LONG FLEXIBLE TUBE. THE HEATED BREATHING TUBE TECHNOLOGY ON THE FPH AIRVO AND MR880 HEATER BASES ARE DESIGNED TO WORK WITH A 320MM LONG UNHEATED EXTENSION ON THE PATIENT INTERFACE, AS PROVIDED BY THE OPT846. THE FPH MR850 HEATER BASE, WHICH IS DESIGNED TO BE USED WITH THE OPT546 IN CRITICAL CARE ENVIRONMENTS DOES NOT HAVE THIS TECHNOLOGY AND THUS REQUIRES AN INTERFACE WITH A SHORTER UNHEATED EXTENSION. THE OPT546 HAS A STANDARD 22MM CONNECTOR. THE OPT846 HAS A PROPRIETARY 15MM CONNECTOR AT THE END OF THE INTERFACE WHICH IS DESIGNED TO PREVENT INADVERTENT CONNECTION OF NON-COMPATIBLE BREATHING CIRCUITS. THE HOSPITAL HAVE ADMITTED THAT THEY USED FORCE TO ATTACH THE OPT846 TO AN INCORRECT BREATHING CIRCUIT AND THE DESATURATION IN THE PATIENT HAS OCCURRED AS A RESULT OF THIS. THE USER INSTRUCTIONS CLEARLY STATE THAT THE OPT846 IS TO BE USED ONLY WITH THE AIRVO MR880 HUMIDIFIERS AND THAT ONLY APPROVED SETUP IS TO BE USED: IN ADDITION, THE PRODUCT BOX LABEL ALSO STATES THAT THE OPT846 IS "TO BE USED WITH MR880 AND AIRVO SERIES" HUMIDIFIERS. AS PART OF OUR COMMITMENT TO ONGOING PRODUCT IMPROVEMENTS, WE ARE CURRENTLY WORKING TO DIFFERENTIATE THE LABELLING OF THE OPT5XX AND OPT8XX SERIES OF OPTIFLOW INTERFACES.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS GAS LEAKAGE AROUND THE CONNECTOR OF AN OPT846 ADULT NASAL INTERFACE. THE HOSPITAL FURTHER REPORTED THAT THE PATIENT DESATURATED TO 96% AND THAT WHEN THE CIRCUIT WAS CHANGED THE ISSUE WAS RECTIFIED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS GAS LEAKAGE AROUND THE CONNECTOR OF AN (B)(4) ADULT NASAL INTERFACE. THE HOSPITAL FURTHER REPORTED THAT THE PATIENT DESATURATED TO 96% AND THAT WHEN THE CIRCUIT WAS CHANGED THE ISSUE WAS RECTIFIED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT846

    Patients

    Seq Age Sex Outcome Treatment
    1