BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 5490756 · Received March 9, 2016

    Report

    Report Number
    9611451-2016-00088
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Report Date
    February 9, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPTFILOW NASAL INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS AND CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE 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. THE COMPLAINT OPTIFLOW CANNULAE ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPTFILOW NASAL INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS AND CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE 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. METHOD: THE COMPLAINT OPT842 (SIZE SMALL) NASAL CANNULAE WERE NOT AVAILABLE FOR EVALUATION AS THEY HAD BEEN DISCARDED BY THE CUSTOMER. INSTEAD ELEVEN SAMPLES FROM THE SAME LOT WERE PROVIDED. IN ADDITION TO THE SAMPLES OF OPT842, THE CUSTOMER PROVIDED UNUSED SAMPLES OF OUR OTHER MODELS AS FOLLOWS: OPT844 MEDIUM NASAL CANNULA: ONE FROM LOT 110709 (MANUFACTURED JULY 9, 2011) AND 12 FROM LOT 150114 (MANUFACTURED JAN 14, 2015). OPT846 LARGE NASAL CANNULA: 10 FROM LOT 100901 (MANUFACTURED SEP 1, 2010). OPT542 SMALL NASAL CANNULA: 14 FROM LOT 131010 (MANUFACTURED OCT 10, 2013) AND 18 FROM LOT 131015 (MANUFACTURED OCT 15, 2013). OPT544 MEDIUM NASAL CANNULA: FOUR FROM LOT 131009 (MANUFACTURED OCT 9, 2013) AND 13 FROM LOT 131011 (MANUFACTURED OCT 11, 2013). OPT546 LARGE NASAL CANNULA: ONE FROM LOT 091221 (MANUFACTURED JULY 9, 2011) AND 12 FROM LOT 150114 (MANUFACTURED JAN 14, 2015). THE PROVIDED SAMPLE CANNULAE WERE VISUALLY INSPECTED. ADDITIONALLY SAMPLE CANNULAE WERE PERFORMANCE TESTED FOR 48 HOURS USING THE CUSTOMER SETTINGS AND A WORKING AIRVO HUMIDIFIER. RESULTS: THE INSPECTION REVEALED THAT ALL OF THE RETURNED CANNULAE WERE WITHIN SPECIFICATION AND WITH NO DAMAGE OR DEFECTS. DURING THE PERFORMANCE TEST THE PERMANCE AND INTEGRITY OF THE PRONGS WERE TESTED AND CHECKED. A NEW PRODUCTION SAMPLE WAS ALSO TESTED UNDER THE SAME CONDITIONS IN PARALLEL WITH THE COMPLAINT SAMPLE. BOTH TESTED CANNULAE FUNCTIONED CORRECTLY AND THERE WAS NO DAMAGE OR KINKING OF THE PRONGS AT THE END OF THE TEST. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT HAD CAUSED THE PROBLEM AS REPORTED BY THE CUSTOMER AS NO FAULT WAS FOUND WITH ANY OF THE PROVIDED SAMPLES. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLOURATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF. THE CUSTOMER ALSO INFORMED US THAT THE CANNULAE WERE USED FOR APPROXIMATELY TWO DAYS BEFORE FAILING. THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT842 SHOW IN PICTORIAL FORMAT THE CORRECT FITTING AND PLACEMENT OF THE CANNULA AND AD VISE THE USER TO "ENSURE NASAL CANNULA IS SIZED CORRECTLY AND DOES NOT CREATE A SEAL IN THE NARES". THEY ALSO. CONTAIN THE FOLLOWING WARNING: APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE PRONGS OF THE OPTIFLOW NASAL CANNULAE WERE KINKING WHILE IN USE ON THE PATIENTS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE PRONGS OF THE OPTIFLOW NASAL CANNULAE WERE KINKING WHILE IN USE ON THE PATIENTS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145483 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT842 100831

    Patients

    Seq Age Sex Outcome Treatment
    1