LIBERATOR
Report
- Report Number
- 3004972304-2025-00004
- Event Type
- Death
- Date Received
- July 16, 2025
- Date of Event
- June 29, 2025
- Report Date
- July 16, 2025
- Manufacturer
- CAIRE INC.
- Product Code
- BYJ
- UDI-DI
- M766132623090
- PMA / PMN Number
- K800742
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. FOLLOW-UP REPORT #2: PER FORM 2500A INSTRUCTIONS, INFORMATION FROM THE INITIAL 30 DAY REPORT AND FOLLOW-UP #1 HAVE NOT BEEN REPEATED IN THIS REPORT. THE LIBERATOR STORES LIQUID OXYGEN AND DELIVERS IT AS GAS FOR PATIENTS REQUIRING SUPPLEMENTAL OXYGEN THERAPY. IT SERVES AS A STATIONARY RESERVOIR AND MAY ALSO REFILL COMPATIBLE PORTABLE UNITS. IT SHOULD BE NOTED THAT THE INTENDED USE OF LIBERATOR UNIT IS TO PROVIDE SUPPLEMENTAL OXYGEN TO INCREASE BLOOD OXYGEN SATURATION. IT IS NOT INDICATED FOR LIFE-SUSTAINING OR LIFE SUPPORT PURPOSES, NOR DOES IT INCLUDE PATIENT MONITORING OR ALARM CAPABILITIES. PATIENTS MUST ALWAYS HAVE A BACKUP OXYGEN SOURCE AVAILABLE. AS SUCH, PATIENT SUPERVISION AND THE MANAGEMENT OF OXYGEN THERAPY REMAIN UNDER THE RESPONSIBILITY OF THE PRESCRIBING HEALTHCARE PROVIDER AS WELL AS THE DISTRIBUTOR AND/OR MAINTAINER. CAIRE COULD NOT CONFIRM PATIENT CAUSE OF DEATH, AS NO AUTOPSY OR CORONER'S REPORT WAS MADE AVAILABLE. THE LIBERATOR UNIT WAS EVALUATED ACCORDING TO A PEER-REVIEWED ENGINEERING TEST PROTOCOL. RETURNED VIGILANCE UNITS ARE VISUALLY INSPECTED FOR POTENTIAL SHIPPING DAMAGE BEFORE AND AFTER UNPACKAGING TO CONFIRM THAT TRANSPORTATION DID NOT AFFECT THE CONDITION OF THE DEVICE. NO PACKAGING DAMAGE WAS OBSERVED EXTERNALLY OR INTERNALLY. ROUTINE OPERATIONAL PERFORMANCE WAS CONDUCTED, AS WAS EVENT REPLICATION OF ELECTRONIC LEVEL GAUGE (ELG) PERFORMANCE. AT THE CLOSE OF EVENT REPLICATION TESTING, THE ELG READING INCORRECTLY INDICATED THE PRESENCE OF REMAINING LOX IN THE EMPTY LIBERATOR UNIT. FOLLOWING THE EVENT REPLICATION TESTING, IT WAS NOTED THAT THE WIRE HARNESS AND INSIDE OF THE SHROUD CONTAINED ICE BUILDUP. THE LIBERATOR TECHNICAL SERVICE MANUAL RECOMMENDS CALLING TECHNICAL SERVICE FOR MAINTENANCE IF THIS OCCURS. CAIRE DOES NOT PERFORM MAINTENANCE ON THIS DISTRIBUTOR'S LIBERATOR FLEET, AND THE MAINTENANCE HISTORY OF THIS SPECIFIC LIBERATOR UNIT IS NOT KNOWN. LIBERATOR RISK ASSESSMENT SLOX-RA-002 REV T WAS REVIEW AND DEEMED ADEQUATE WITHOUT REVISION. DFMECA ANALYSIS ENTRIES CI-9, CI-10, CI-11, AND CI-13 ADDRESS THE HARNESS, WHICH CONNECTS THE CAPACITANCE METER TO THE PROBE.
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 CONTACTED THE DISTRIBUTOR, OXYSPHAIR, TO GATHER ADDITIONAL INFORMATION REGARDING ALL CAIRE DEVICES IN THE PATIENT'S HOME. OXYSPHAIR AND CAIRE WILL REQUEST THAT THE DEVICE BE RELEASED FROM POLICE CUSTODY AND SENT TO CAIRE'S LANGENFELD, GERMANY FACILITY FOR EVALUATION. CAIRE WILL CONDUCT AN EVALUATION OF THE DEVICE, IF POSSIBLE. A FOLLOW UP AND FINAL REPORT WILL BE SUBMITTED. NOTE: THE INTENDED USE OF LIBERATOR LIQUID OXYGEN BASE IS SUPPLEMENTAL OXYGEN TO INCREASE BLOOD OXYGEN SATURATION. IT IS NOT INDICATED FOR LIFE SUSTAINING OR LIFE SUPPORT ACTIVITIES. LIBERATOR DOES NOT HAVE PATIENT SURVEILLANCE CAPABILITIES. PER THE INITIAL REPORT, "THE PATIENT'S MOBILE PHONE, USUALLY KEPT WITHIN REACH TO CALL FOR HELP, WAS FOUND ON THE FLOOR, SUGGESTING AN ATTEMPT TO CALL DURING THE NIGHT." A MOBILE PHONE IS NOT AN ADEQUATE PATIENT SURVEILLANCE SYSTEM. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(8). THE DEVICE WAS INTENDED FOR EXPORT ONLY.
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. FOLLOW-UP REPORT #1: 1. SECTION D4: UDI NUMBER ADDED. 2. CAIRE INC RECEIVED THE INCIDENT UNIT, SERIAL NUMBER (B)(6) AT CAIRE'S (B)(6) FACILITY ON 15 AUGUST 2025. AN ENGINEERING EVALUATION WILL BE CONDUCTED. THE TARGET COMPLETION DATE IS 11 OCTOBER 2025.
AS REPORTED: AN ADDITIONAL OXYGEN TANK WAS DELIVERED ON (B)(6) 2025 TO A PATIENT'S HOME DUE TO INCREASED OXYGEN NEEDS. THE TANK WAS FIRST CONNECTED AND USED ON FRIDAY, ON (B)(6) 2025. IT FUNCTIONED NORMALLY: THE LED INDICATORS WERE FULLY GREEN, AND OXYGEN WAS BEING DELIVERED PROPERLY. ON SATURDAY, ON (B)(6) 2025, AROUND 11:00 P.M., A ROUTINE CHECK WAS PERFORMED. ALL CONNECTIONS WERE IN ORDER, THE LED INDICATORS REMAINED GREEN, AND OXYGEN APPEARED TO BE AVAILABLE IN SUFFICIENT QUANTITY. THE PATIENT WAS SLEEPING IN A HOSPITAL BED IN THE LIVING ROOM, WEARING A NASAL CANNULA. OTHER HOUSEHOLD MEMBERS WERE ASLEEP IN THEIR RESPECTIVE ROOMS. ON THE MORNING OF SUNDAY, ON (B)(6) 2025, AT APPROXIMATELY 6:40 A.M., THE PATIENT WAS FOUND DECEASED IN BED. THE NASAL CANNULA WAS STILL IN PLACE AND CORRECTLY CONNECTED TO THE TANK, BUT NO OXYGEN WAS FLOWING, DESPITE THE LED INDICATORS STILL SHOWING GREEN. ANOTHER TANK WAS IMMEDIATELY CONNECTED, AND OXYGEN FLOWED NORMALLY. CPR WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT'S MOBILE PHONE, USUALLY KEPT WITHIN REACH TO CALL FOR HELP, WAS FOUND ON THE FLOOR, SUGGESTING AN ATTEMPT TO CALL DURING THE NIGHT. ON (B)(6) 2025, A CALL WAS MADE TO THE SUPPLIER. AS IT WAS A SUNDAY, A TECHNICIAN ANSWERED AND GAVE A CONFUSED EXPLANATION, MENTIONING THAT AN ALARM SHOULD HAVE SOUNDED IN CASE OF OXYGEN FAILURE. HOWEVER, THE TECHNICIAN WAS REFERRING TO A DIFFERENT DEVICE. THE CALLER WAS ADVISED TO CONTACT THE MAIN OFFICE THE NEXT MORNING. ON 30/06/2025, THE MAIN OFFICE WAS CONTACTED. IT WAS CONFIRMED THAT THE MODEL IN QUESTION, THE LIBERATOR, DOES NOT HAVE A BUILT-IN ALARM SYSTEM, WHICH THE FAMILY WAS ALREADY AWARE OF AFTER SEVERAL YEARS OF USE. THAT SAME DAY, THE PATIENT'S GENERAL PRACTITIONER INITIATED A JUDICIAL INVESTIGATION. THE PUBLIC PROSECUTOR'S OFFICE WAS NOTIFIED. THE OXYGEN TANKS WERE SEALED ON-SITE BY THE POLICE AND PLACED IN A SEPARATE ROOM IN THE HOME. THE OFFICERS ATTEMPTED TO WEIGH THE TANKS USING A HOUSEHOLD SCALE, WHICH WAS NOT SUITABLE FOR SUCH HEAVY EQUIPMENT. ONE OF THE OFFICERS EXPRESSED DOUBT ABOUT THE RELIABILITY OF THIS METHOD, BUT THE WEIGHING WAS CARRIED OUT FOR REPORTING PURPOSES. THE TANKS REMAIN SEALED AT THE RESIDENCE, WITH A POLICE NOTICE ATTACHED INDICATING A "SUSPICIOUS DEATH." AN AUTOPSY WAS PERFORMED ON (B)(6) 2025 AT (B)(6) HOSPITAL. THE CASE IS REGISTERED UNDER A PV NUMBER WITH THE PUBLIC PROSECUTOR'S OFFICE, UNDER THE SUPERVISION OF A DEPUTY PUBLIC PROSECUTOR. CONTACT DETAILS ARE AVAILABLE UPON REQUEST FOR OFFICIAL FOLLOW-UP. THE INCIDENT WAS ALSO REPORTED TO THE FEDERAL PUBLIC SERVICE (FPS) HEALTH VIA EMAIL ON 08/07/2025. A RESPONSE WAS RECEIVED FROM THE DEPUTY PROSECUTOR, BUT IT IS RECOMMENDED TO CONTACT HER DIRECTLY FOR FURTHER INFORMATION. IT IS UNDERSTOOD THAT THE PUBLIC PROSECUTOR'S OFFICE WILL NOT CONDUCT A TECHNICAL INVESTIGATION. THEREFORE, AN INDEPENDENT TECHNICAL ANALYSIS IS NECESSARY TO DETERMINE WHETHER A MALFUNCTION OCCURRED THAT CAUSED AN INTERRUPTION IN OXYGEN DELIVERY, DESPITE THE LED INDICATORS SHOWING NORMAL STATUS. SUCH AN INVESTIGATION IS CRUCIAL TO PREVENT SIMILAR INCIDENTS IN THE FUTURE. THE SEALED TANKS REMAIN IN THE HOME, WHICH IS A DAILY EMOTIONAL BURDEN FOR THE FAMILY. A THOROUGH TECHNICAL EXAMINATION OF THE TANK IS STRONGLY REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1561391 | LIBERATOR | UNIT, LIQUID OXYGEN, STATIONARY | BYJ | CAIRE INC. | 13262309 | M766132623090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |