BEUDAMED
    FDA Adverse Event Death Summary report: N

    NASAL INTERFACE

    MDR report key: 11936584 · Received June 3, 2021

    Report

    Report Number
    9611451-2021-00650
    Event Type
    Death
    Date Received
    June 3, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 7, 2021
    Product Code
    BTT
    UDI-DI
    09420012429117
    PMA / PMN Number
    K162553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE OPT944 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. THE OPT944 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. METHOD: THE SUBJECT OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS:THE HEALTHCARE FACILITY REPORTED THAT A CRITICALLY UNSTABLE PATIENT WITH SEVERAL PRE-EXISTING CONDITIONS ATTEMPTED TO GET OUT OF BED AND WAS FOUND TO HAVE DESATURATED, WAS UNCONSCIOUS ON HIS BED AND THE OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND ON THE FLOOR. IT WAS FURTHER REPORTED THAT THE PATIENT DECEASED DESPITE RAPID RESTORATION OF PATIENT OXYGEN SATURATION LEVELS. THERE WAS NO REPORTED DAMAGE OF THE SUBJECT OPTIFLOW + OPT944 ADULT NASAL CANNULA. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE SUBJECT OPT944 WAS FOUND INTACT ON THE FLOOR WITH NO DAMAGE TO THE CANNULA. CONCLUSION: AS THERE WAS NO REPORTED MALFUNCTION WITH THE SUBJECT OPT944 CANNULA, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE HEALTHCARE FACILITY REPORTED THAT THE SUBJECT OPT944 WAS FOUND INTACT ON THE FLOOR WITH NO DAMAGE TO THE CANNULA. IT SHOULD BE NOTED THE PATIENT WAS CRITICALLY UNSTABLE WITH SEVERAL PRE-EXISTING CONDITIONS. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE MEDICAL CAUSE OF DEATH WAS ACUTE DESATURATION FOR 15-20 MINUTES. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLORATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF OR REPROCESSED. THE SUBJECT OPT944 OPTIFLOW + ADULT NASAL CANNULA WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT944 OPTIFLOW + ADULT NASAL CANNULA SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT AND FITTING OF THE CANNULA AND STATES: "ENSURE HEADSTRAP CLIP IS ATTACHED, TO PREVENT CANNULA FROM BEING PULLED OUT OF THE NARES." "CANNULA CAN BECOME UNATTACHED IF NOT USED WITH THE HEADSTRAP CLIP." "ATTACH TUBING CLIP TO CLOTHING/BEDDING TO PREVENT CANNULA FROM PULLING OFF FACE." "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH." "FAILURE TO USE THE SET-UP DESCRIBED ABOVE CAN COMPROMISE PERFORMANCE AND AFFECT PATIENT SAFETY."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED THAT A CRITICALLY UNSTABLE PATIENT WITH SEVERAL PRE-EXISTING CONDITIONS ATTEMPTED TO GET OUT OF BED AND WAS FOUND TO HAVE DESATURATED, WAS UNCONSCIOUS ON HIS BED AND THE OPT944 OPTIFLOW ADULT NASAL CANNULA WAS FOUND ON THE FLOOR. IT WAS FURTHER REPORTED THAT THE PATIENT DECEASED DESPITE RAPID RESTORATION OF PATIENT OXYGEN SATURATION LEVELS. THERE WAS NO REPORTED DAMAGE OF THE SUBJECT OPTIFLOW OPT944 ADULT NASAL CANNULA. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE SUBJECT OPT944 WAS FOUND INTACT ON THE FLOOR WITH NO DAMAGE TO THE CANNULA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT OPT944 OPTIFLOW ADULT NASAL CANNULA IS NOT EXPECTED TO RETURN TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE ARE CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION WITH REGARDS TO THE REPORTED EVENT . WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT A CRITICALLY UNSTABLE PATIENT WITH SEVERAL PRE-EXISTING CONDITIONS ATTEMPTED TO GET OUT OF BED AND WAS FOUND TO HAVE DESATURATED, WAS UNCONSCIOUS ON HIS BED AND THE OPT944 OPTIFLOW ADULT NASAL CANNULA WAS FOUND ON THE FLOOR. IT WAS FURTHER REPORTED THAT THE PATIENT DECEASED DESPITE RAPID RESTORATION OF PATIENT OXYGEN SATURATION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832699 NASAL INTERFACE BTT BTT OPT944 2100845229 09420012429117

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death