BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERATOR

    MDR report key: 15827497 · Received November 18, 2022

    Report

    Report Number
    3004972304-2022-00044
    Event Type
    Death
    Date Received
    November 18, 2022
    Date of Event
    September 19, 2022
    Report Date
    June 6, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    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. CAIRE IS CONTACTING (B)(4) TO OBTAIN MORE INFORMATION ABOUT THE INCIDENT, AS WELL AS TO HAVE THE UNITS RETURNED FOR AN INVESTIGATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 STROLLER PORTABLE AND LIBERATOR STATIONARY UNITS WERE INVOLVED IN A HIGH HEAT EVENT, AS PARTS OF EACH UNIT WERE EITHER MELTED, DEFORMED OR MISCOLORED. THE INVESTIGATION DETERMINED THAT THE STROLLER PORTABLE UNIT WAS CONNECTED TO THE LIBERATOR STATIONARY UNIT SIDE FILL QUICK DISCONNECT VALVE (QDV) DURING THE FIRE/EXPLOSION INCIDENT, BUT IT CANNOT BE DETERMINED IF THE QDV WAS OPEN AT THE TIME OF THE EVENT. THE VACUUM POP OUT ON THE LIBERATOR STATIONARY UNIT WAS STILL INTACT AFTER THE EVENT, THEREFORE THE UNIT STILL HAD VACUUM. IT WAS DETERMINED THAT THE UNIT WAS SET TO 6 LPM VIA THE FLOW CONTROL VALVE (FCV). MOST OF THE DAMAGE TO THE PLUMBING HAPPENED ON TOP HALF OF THE LIBERATOR STATIONARY UNIT AS THE BOTTOM HALF WAS NOT MISCOLORED. BASED ON THE AVAILABLE EVIDENCE, THE INVESTIGATION DETERMINED THAT THE UNITS WERE ATTACHED AT THE TIME OF THE FIRE/EXPLOSION INCIDENT, AND THAT THE FIRE/EXPLOSION INCIDENT HAPPENED EXTERNAL TO THE UNITS. IFU MN236 STATES THE FLOW CONTROL MUST BE IN THE OFF POSITION ON BOTH THE PORTABLE AND STATIONARY UNITS PRIOR TO CONNECTION FOR FILLING. THE FLOW SHOULD HAVE BEEN OFF, AND THE UNITS SHOULD NOT HAVE BEEN IN USE, AT THE TIME OF THE FIRE/EXPLOSION INCIDENT. BASED ON THIS INFORMATION, IT IS LOGICAL TO ASSUME THAT THE UNIT WAS INCIDENTAL TO THE FIRE AND NOT A CONTRIBUTING CAUSE. NO FURTHER TESTING REQUIRED. RISK ASSESSMENTS SLOX-RA-001, REV P AND PLOX-RA-002, REV L WERE REVIEWED AND FOUND TO BE ADEQUATE WITHOUT REVISION. THE USABILITY ASSESSMENT, LINES FIRE-1 THROUGH FIRE-3 ADDRESS THE USER PLACING THE DEVICE IN AN AREA OF LIMITED VENTILATION AND USING IN CLOSE PROXIMITY TO A FLAMMABLE SOURCE, INCLUDING A CIGARETTE. OXYGEN MAY ACCELERATE NEARBY FIRE HAZARDS. THIS INFORMATION IS INCLUDED IN LIBERATOR IFU MN234, AS WELL AS WARNING LABELS ON THE LIBERATOR STATIONARY UNIT REGARDING SMOKING AND USE NEAR OPEN FLAME. ADDITIONALLY, THE USABILITY ASSESSMENT LINES USERIN-7 THROUGH USERIN-14 ADDRESS THE HAZARDS AND HARMS ASSOCIATED WITH FAILING TO FOLLOW THE IFU WHILE FILLING THE PORTABLE UNIT FROM A STATIONARY UNIT. THIS INFORMATION IS INCLUDED IN IFU MN234 AND MN236.

    Description of Event or Problem · 0

    ON OCTOBER 20, 2022, CAIRE RECEIVED A NOTIFICATION FROM (B)(4) OF THE FOLLOWING INCIDENT: THE LIBERATOR DEVICE EXPLODED, AND THE PATIENT DIED. (B)(4) ALSO INCLUDED THE DEVICE INFORMATION FOR A STROLLER PORTABLE LIQUID OXYGEN DEVICE (S/N (B)(4)), BUT IT IS NOT CLEAR HOW THIS DEVICE WAS INVOLVED IN THE INCIDENT. REF. MEDWATCH REPORT # 3004972304-2022-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229052 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13261701

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death