BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI FLOW STROLLER

    MDR report key: 16635792 · Received March 29, 2023

    Report

    Report Number
    3004972304-2023-00007
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 3, 2023
    Report Date
    August 25, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. THE HI FLOW STROLLER UNIT WAS SUBJECTED TO PRESSURE LEAK TESTING AND FUNCTIONAL TESTING UNDER NORMAL USE CONDITIONS. THE UNIT PASSED ALL PRESSURE LEAK TESTING AND FUNCTIONAL TESTING AS SET OUT IN THE PROTOCOL. THE UNIT WAS SUBJECTED TO ADDITIONAL DEVIATION TESTING IN AN ATTEMPT TO ACCURATELY RECREATE THE CONDITIONS AT THE TIME OF THE REPORTED EVENT. TO SIMULATE SKIING, ADDITIONAL FLOW TESTING WAS CONDUCTED WITH THE UNIT AT VARIOUS ANGLES OUTSIDE OF THE NORMAL ORIENTATION OF USE. DURING THE DEVIATION TESTING, THE UNIT OPERATED AS EXPECTED AT ANGLES UP TO 10 DEGREES FROM A HORIZONTAL POSITION. THE UNIT'S PRESSURE RELEASE VALVE (PRV) WOULD OPEN AT 10 DEGREES FROM HORIZONTAL, CREATING CONDITIONS FOR A LIQUID OXYGEN LEAK. NO LIQUID OXYGEN ESCAPED THE UNIT AT ANY ANGLE HIGHER THAN 10 DEGREES FROM HORIZONTAL. AT THE TIME OF THE REPORTED EVENT, THE UNIT WAS LIKELY AT A NEAR-HORIZONTAL POSITION TO CREATE A LIQUID OXYGEN LEAK. THE USER MANUAL INSTRUCTS THAT THE UNIT MUST BE USED AND STORED IN AN UPRIGHT POSITION AND WELL VENTILATED. TO SIMULATE THE SKIING LOCATION, ALTITUDE-ENVIRONMENTAL CHAMBER TESTING WAS CONDUCTED AT 10,000 FEET (3048 METERS) AND 24.8°F (-4°C) AT 8 LPM USING THE AUTHORIZED CAIRE BACKPACK ACCESSORY, WHICH PROVIDES THE APPROPRIATE AMOUNT OF VENTILATION. LIQUID OXYGEN WILL NOT ENTER THE CANNULA UNDER NORMAL USE AND PROPER VENTILATION. THERMAL COUPLE DATA GENERATED DURING TESTING CONCLUDED THAT LIQUID OXYGEN DID NOT EXIT THE CANNULA, AS THE TEMPERATURE OF THE CANNULA OUTLET ONLY REACHED AIR TEMPERATURE OF THE CHAMBER. THE EQUIPMENT PROVIDER SUPPLIED PHOTOS OF THE BACKPACK USED AT THE TIME OF THE INCIDENT, CONFIRMING IT WAS NOT THE AUTHORIZED CAIRE BACKPACK ACCESSORY. IMPROPER VENTILATION MAY HAVE BEEN AN ADDITIONAL CONTRIBUTING FACTOR TO THE REPORTED ADVERSE EVENT. RISK ASSESSMENT (B)(4) WAS REVIEWED AND WAS DETERMINED THAT AN UPDATE IS NEEDED TO ADD A STATEMENT AGAINST THE USE OF UNAUTHORIZED ACCESSORIES. HOWEVER, THE RA FILE IN THE TOP-DOWN ASSESSMENT LINES TD-1 AND TD-9 ADDRESSES THE USER ALLOWING FOR THE UNIT TO NOT BE KEPT IN AN UPRIGHT POSITION. DOING SO MIGHT CAUSE A THERMAL INJURY FROM COLD. INFORMATION REGARDING THIS IS LISTED IN THE STROLLER IFU, MN236, AS WELL AS HAVING UPRIGHT ARROWS ON THE DEVICE.

    Additional Manufacturer Narrative · 0

    PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO CAIRE'S BALL GROUND, GA, USA FACILITY FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    CAIRE WAS NOTIFIED 10 MAR 2023 BY (B)(6) THAT A PATIENT SUFFERED COLD BURNS ON THE FACE, NECK, AND INSIDE THE NOSE WHILE USING A HI FLOW STROLLER DURING SKIING. THE PATIENT REMOVED THE SKI HELMET AND PULLED DOWN THE OXYGEN TUBE, WHICH WAS FULLY ICED ON THE CHEEKS, NECK, AND NOSE. THE BURN WAS SAID TO HAVE BEEN CAUSED BY LIQUID OXYGEN, WHICH WAS DESCRIBED AS HAVING SPRAYED FROM THE DEVICE. THE PATIENT REPORTED THE INCIDENT OCCURED ON (B)(6) 2023. MEDICAL ATTENTION WAS SOUGHT FROM THE OUTPATIENT DEPARTMENT OF A LOCAL HOSPITAL ON (B)(6) 2023, PRIMARY PHYSICAN ON (B)(6) 2023, AND ENT SPECIALIST ON (B)(6) 2023. THE PATIENT WAS DIAGNOSED WITH SEVERE INFLAMMATION OF THE NOSE, SEVERE SWELLING OF THE LOWER EYE LID, AND COLD BURNS ALONG THE PATH OF THE TUBE FROM THE CHEEK TO THE NECK. IN A FOLLOW UP ON 20 MARCH 2023 THE PATIENT NOTED SOME BUT NOT COMPLETE RECOVERY. HE ADDED THAT HE HAD NOT HAD A FALL ON THE SKI SLOPE WHILE WEARING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007294 HI FLOW STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 14778770

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization