BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 19752112 · Received July 16, 2024

    Report

    Report Number
    3004972304-2024-00008
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 23, 2024
    Report Date
    September 23, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    UDI-DI
    M766108452000
    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 INCIDENT AS DESCRIBED IS TYPICALLY CAUSED BY IMPROPER CLEANING OF THE VALVE, LEADING TO ICE BUILD UP HOLDING THE VALVE OPEN. DISTRIBUTOR AIR LIQUIDE QUARANTINED THE UNIT AT THEIR AUSTRIAN FACILITY. CAIRE TECHNICAL SERVICE PERSONNEL WILL VISIT THE FACILITY TO PERFORM A UNIT EVALUATION ON SITE. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION WHEN AVAILABLE.

    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. AN ENGINEERING EVALUATION WAS CONDUCTED BY CAIRE'S TECHNICAL TEAM AT THE AIR LIQUIDE AUSTRIA FACILITY, WITH FINAL ANALYSIS AND COMPLETION PERFORMED BY CAIRE'S US LIQUID OXYGEN ENGINEERING TEAM. THE STROLLER HAD NORMAL WEAR ON THE QDV. PER THE ENGINEERING REPORT: THE ONLY TEST THAT FAILED WAS THE PRESSURE RELIEF VALVE (PRV) OPENING PRESSURE, AS IT OPENED 0.5 PSI ABOVE SPECIFICATION AT 21.5 PSI. THIS DOES NOT AFFECT SAFETY OF THE UNIT AS THE SECONDARY RELIEF VALVE (SRV) IS THE SAFETY VALVE. ALL OTHER TESTING SECTIONS PASSED INCLUDING THE EVENT REPLICATION SECTION. EVENT REPLICATION: SPECIFIC LIBERATOR STATIONARY UNIT (B)(6) AND SPECIFIC STROLLER PORTABLE UNIT (B)(6) WERE TESTED TOGETHER IN A FILL PROCESS IN AN ATTEMPT TO REPLICATE THE EVENT. PER PROTOCOL, THE VALVES WERE CLEANED BEFORE THE FILLING PROCESS FOR SAFETY. NO LEAKAGE OR ANOMALIES WERE OBSERVED DURING THE EVENT REPLICATION TEST; THE EVENT COULD NOT BE REPLICATED BY CAIRE. PLOX-RA-002 REV M: LINE TD-6 FOR THE TOP-DOWN ANALYSIS INCLUDES NOTICE OF USING A QDV CLEANING KIT PRIOR TO USING THE QDV CONNECTIONS. THIS LINE ALSO POINTS TO INSTRUCTIONS IN THE USER MANUAL, MN236.

    Description of Event or Problem · 0

    AS REPORTED: THE PATIENT WANTED TO FILL THE LIQUID PORTABLE UNIT (SIDE FILL), BOTH CONNECTIONS WERE DRIED. THE LIQUID BASE UNIT BEGAN TO MIST AND ICE UP SO THAT THE CUSTOMER COULD HARDLY SEE ANYTHING. WHEN SHE TRIED TO SEPARATE THE LIQUID PORTABLE UNIT FROM THE LIQUID BASE UNIT (USING A CLOTH), SHE TOUCHED THE VALVE OF THE LIQUID BASE UNIT WITH HER LEFT HAND. THE PATIENT SUFFERED COLD BURNS ON HER ENTIRE RING FINGER AND HALF OF HER MIDDLE FINGER ON HER LEFT HAND - TWO LARGE BLISTERS, WHICH WERE TREATED WITH AN OINTMENT. THE PATIENT WAS SEEN BY HER DOCTOR AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748743 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 10845200 M766108452000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| O