BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 5698085 · Received June 3, 2016

    Report

    Report Number
    9611451-2016-00242
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 10, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT94X 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 FEATURES A HEAD STRAP CLIP WHICH WORKS IN TANDEM WITH THE TUBING CLIP (ATTACHES TO THE PATIENT'S CLOTHING/BEDDING) TO SUPPORT THE WEIGHT OF THE CIRCUIT AND PREVENT THE CANNULA BEING DISLODGED. METHOD: TWO OPT944 (MEDIUM SIZE) AND ONE OPT946 (LARGE SIZE) WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE, (B)(4), AND WERE VISUALLY INSPECTED. THE OPT946 CANNULA WAS FROM LOT 151218, MANUFACTURED ON DECEMBER 8, 2015. ONE OPT944 CANNULA WAS FROM LOT 160308, MANUFACTURED ON MARCH 8, 2016. NO LOT INFORMATION WAS PROVIDED FOR THE SECOND OPT944 CANNULA. RESULTS: VISUAL INSPECTION OF THE SUBJECT CANNULAE REVEALED THAT IN ALL THREE CASES THE TUBING WAS DETACHED SWIVEL CONNECTOR. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS FOR EITHER OF THE LOT NUMBERS PROVIDED. CONCLUSION: THE OBSERVED DAMAGE IS MOST LIKELY THE RESULT OF PULLING ON THE CANNULA TUBING WITH UNDUE FORCE. 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 SETUP INSTRUCTIONS IN THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT94X NASAL CANNULA INCLUDE THE FOLLOWING STEPS: ENSURE HEAD STRAP CLIP IS ATTACHED, TO PREVENT CANNULA FROM BEING PULLED OUT OF THE NARES; CANNULA CAN BECOME UNATTACHED IF NOT USED WITH THE HEAD STRAP CLIP; ATTACH TUBING CLIP TO CLOTHING/BEDDING TO PREVENT CANNULA FROM PULLING OFF FACE. THE USER INSTRUCTIONS ALSO CONTAIN THE FOLLOWING WARNINGS/CAUTIONS: DO NOT CRUSH OR STRETCH TUBE, TO PREVENT LOSS OF THERAPY; FAILURE TO USE THE SET-UP DESCRIBED ABOVE CAN COMPROMISE PERFORMANCE AND AFFECT PATIENT SAFETY. OUR OPTIFLOW PRODUCTION TEAM HAS BEEN NOTIFIED OF THIS FAILURE. THEY HAVE CARRIED OUT AN INTERNAL REVIEW OF THE MANUFACTURING PROCESS AND PRODUCTION STAFF HAVE RECEIVED ADDITIONAL TRAINING TO ENSURE THEY ARE FOLLOWING THE CORRECT ASSEMBLY PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THREE OPT946 NASAL CANNULAE CAME APART BETWEEN THE TUBING AND THE CONNECTOR. IN ONE CASE A PATIENT ON NASAL HIGH FLOW OXYGEN THERAPY BEGAN TO DESATURATE DESPITE INCREASING FIO2 DELIVERY; AS THE PATIENT WAS BEING TRANSFERRED BACK TO BED STAFF NOTED THAT THE CANNULA TUBING HAD BECOME DETACHED FROM THE CONNECTOR. IT WAS FURTHER REPORTED THAT THE PATIENT'S SPO2 DROPPED TO 58% AND THEY WERE PUT ONTO NON INVASIVE CPAP VENTILATION FOR 10 HOURS UNTIL STABLE ENOUGH TO BE WEANED BACK ONTO NASAL HIGH FLOW THERAPY. NO PATIENT CONSEQUENCE WAS REPORTED FOR THE OTHER TWO INCIDENTS.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THREE OPT946 NASAL CANNULAE CAME APART BETWEEN THE TUBING AND THE CONNECTOR. IN ONE CASE A PATIENT ON NASAL HIGH FLOW OXYGEN THERAPY BEGAN TO DESATURATE DESPITE INCREASING FIO2 DELIVERY; AS THE PATIENT WAS BEING TRANSFERRED BACK TO BED STAFF NOTED THAT THE CANNULA TUBING HAD BECOME DETACHED FROM THE CONNECTOR. IT WAS FURTHER REPORTED THAT THE PATIENT'S SPO2 DROPPED TO 58% AND THEY WERE PUT ONTO NON INVASIVE CPAP VENTILATION FOR 10 HOURS UNTIL STABLE ENOUGH TO BE WEANED BACK ONTO NASAL HIGH FLOW THERAPY. NO PATIENT CONSEQUENCE WAS REPORTED FOR THE OTHER TWO INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351686 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT946 2100014452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention