BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR

    MDR report key: 19567361 · Received June 19, 2024

    Report

    Report Number
    3004972304-2024-00004
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 5, 2024
    Report Date
    September 3, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. AN ENGINEERING EVALUATION WAS CONDUCTED AT CAIRE'S (B)(6), GERMANY FACILITY, WITH FINAL ANALYSIS AND COMPLETION PERFORMED BY CAIRE'S US LIQUID OXYGEN ENGINEERING TEAM. ALL TEST RESULTS WERE ACCEPTABLE. EVENT REPLICATION: SPECIFIC LIBERATOR STATIONARY UNIT (B)(4) AND SPECIFIC STROLLER PORTABLE UNIT (B)(4) WERE TESTED TOGETHER IN A FILL PROCESS IN AN ATTEMPT TO REPLICATE THE EVENT. NOTE: THE EVENT DESCRIPTION REFERENCES A HOSE, HOWEVER CAIRE EQUIPMENT DOES NOT HAVE HOSES. THIS WAS TAKEN TO MEAN THE VALVE CONNECTION. NO ANOMALIES WERE RECORDED DURING THE EVENT REPLICATION TEST; THE EVENT COULD NOT BE REPLICATED BY CAIRE. WE REGRET THAT CAIRE COULD NOT DUPLICATE THE EVENT. ALSO, TO OUR KNOWLEDGE THE USER WAS UNTRAINED AND THE SEVERE INJURY WAS NOT CAUSED BY A MALFUNCTION RELATED TO MANUFACTURING, DESIGN, OR THE SAFETY OF THE SYSTEM. CAIRE STATIONARY LIQUID OXYGEN SYSTEM RISK ASSESSMENT SLOX-RA-001 REV S WAS REVIEWED AND FOUND TO BE ADEQUATE WITH NO UPDATE REQUIRED. NOTE: D4 UDI NUMBER INCLUDED MISSING FROM INITIAL REPORT. H4 UPDATED WITH CORRECTED MANUFACTURE DATE.

    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 LANGENFELD, GERMANY 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

    FULL DESCRIPTION, VERBATIM, AS PROVIDED BY THE REPORTER: AS REPORTED: ON 15.05.2024 A FAX WAS RECEIVED AT THE CUSTOMER SERVICE CENTER SENT FROM STYRIAN CHAMBER OF LABOUR AND EMPLOYEES REGARDING "PRODUCT LIABILITY / SERIOUS PERSONAL INJURY / DEFECTIVE OXYGEN TANK VALVE" . ACCORDING TO THE LETTER, IT CONCERNS THE LIBERATOR45 (B)(6). THE SON-IN-LAW OF THE PATIENT NR (B)(6) SUFFERED SEVERE COLD BURNS ON 5TH OF MAY 2024 AT 10:15 AM. "WHEN THE HOSE WAS DETACHED FROM THE VALVE, A MASSIVE LEAKAGE OF LIQUID OXYGEN OCCURRED AND THE RIGHT ARM OF THE PERSON AFFECTED WAS SEVERELY INJURED." HE WAS TREATED AS AN INPATIENT AT THE REGIONAL HOSPITAL GRAZ UNTIL 8TH OF MAY 2024 AND SUFFERED FROSTBITE OF AT LEAST 2ND DEGREE (2ND DEGREE TYPE A AND/OR TYPE B) ON HIS RIGHT HAND. IT WILL BE DECIDED IN THE COMING MONTHS WHETHER IT WILL BE POSSIBLE TO SAVE ALL OF HIS FINGERS." THE LETTER POINTS OUT THAT THIS IS A PRODUCT LIABILITY CASE AND CLAIMS ARE BEING MADE IN ACCORDANCE WITH THE PRODUCT LIABILITY LAW. THE EVENT COLD BURN IS ASSESSED AS SERIOUS, THE PATIENT IS NOT YET RECOVERED, THE RELATEDNESS WITH LOX IS ASSESSED AS POSSIBLE. A FOLLOW-UP IS PLANNED DUE TO MORE DETAILS OF THE COURSE OF THE EVENT, THE INVESTIGATION REPORT OF CYLINDER AND THE FURTHER OUTCOME OF THE EVENT IN CALENDAR WEEK 21-22. 21.05.2024 FUP DETAILS OF COURSE OF THE EVENT AND INVESTIGATION REPORT OF CYLINDER RECEIVED: THE DRIVER WHO CHANGED THE CYLINDERS ON 16.05.2024 RECEIVED FOLLOWING COURSE OF THE EVENT: THE RELATIVE CONCERNED FILLED THE MOBILE DEVICE, A STROLLER SIDEFILL, AS USUAL BUT HE HEARD A DIFFERENT FILLING NOTICE THAN USUAL. AFTER JUST UNDER A MINUTE, HE TRIED TO DISCONNECT THE STROLLER FROM THE LIBERATOR AND THEN THE LIQUID OXYGEN FLOW OUT. HE WAS SHOCKED AND REMAINED IN THE POSITION FOR A FEW SECONDS AND ONLY THEN HE MOVED AWAY. THE LIBERATOR (SERIAL NUMBER (B)(6) WAS CHECKED ON 21.05.2024 AND THE REPORT IS AS FOLLOWS: THE DEVICE HAS BEEN CHECKED - NO DAMAGE WAS FOUND. DEVICE IS OKAY. FURTHER MORE THE STROLLER SIDEFILL (SERIAL NUMBER (B)(6) WAS PROOFED TOO AND REPORT SAIS: THE DEVICE HAS BEEN CHECKED, NO DAMAGE OR LEAKS FOUND. THE DEVICE CAN BE RELEASED. 22.05.2024 FUP 2 LVO RECEIVED THE AUTHORIZATION TO CONTACT THE SON-IN-LAW CONCERNED - THE PHONE CALL REVEALED FOLLOWING: IT WAS JUST LUNCHTIME AND THE HARMED PERSON WANTED TO FILL THE MOBILE OXYGEN UNIT FOR HIS FATHER-IN-LAW, WHICH HE HAD ALREADY FILLED MANY TIMES. HE EMPHASISED THAT THE LOX TANK WAS NEW AND THAT NO MOBILE FILLING HAD EVER TAKEN PLACE BEFORE. HE PLACED THE MOBILE DEVICE ON TOP AND STARTED THE FILLING PROCESS BY PRESSING THE BLACK LEVER. THE FILLING PROCESS STARTED, BUT 5-10 SECONDS LATER HE HEARD AN UNUSUAL NOISE AND WANTED TO STOP THE FILLING PROCESS. HE CLOSED THE VALVE AND PRESSED THE LEVER DOWN. SUDDENLY THE LIQUID O2 SHOT OUT VIOLENTLY AND FLOWED OVER HIS RIGHT HAND. IN SHOCK, HE DID NOT IMMEDIATELY WITHDRAW HIS HAND, BUT THEN SOMEHOW PUT THE MOBILE DEVICE DOWN AS HIS RIGHT HAND BEGAN TO HURT BADLY. HIS LEFT HAND WAS NOT AFFECTED. HE REPORTS THAT HE WAS AT THE PLASTIC OUTPATIENT CLINIC TODAY [NOTE: CLINICAL DEPARTMENT FOR PLASTIC, AESTHETIC AND RECONSTRUCTIVE SURGERY], HE READ OUT THE FINDINGS HE RECEIVED TODAY AND THEN SENT THEM BY EMAIL. THE DIAGNOSIS IS 3RD DEGREE FROSTBITE OF THE RIGHT HAND. HE WAS TOLD VERBALLY THAT THE CHARRED INDEX FINGER CAN NO LONGER BE SAVED AND WILL HAVE TO BE AMPUTATED. IT IS ALSO PLANNED TO SURGICALLY REMOVE THE NECROTIC TISSUE ON THE SEVERELY AFFECTED THUMB AND MIDDLE FINGER AND TO PERFORM A SKIN GRAFT (REMOVAL FROM THE THIGH). HE WAS GIVEN ANTIBIOTICS (PENICILLIN) FOR A WEEK AND TAKES A PAINKILLER 3 TIMES A DAY. HE GOES TO THE OUTPATIENT CLINIC EVERY 2-3 DAYS FOR A DRESSING CHANGE. WHEN ASKED HOW HE IS FEELING AT THE MOMENT, HE SAID THAT HE IS IN CONSTANT PAIN, CAN'T SLEEP WELL AND HAS NIGHTMARES, THAT HE ISN'T FEELING WELL AT ALL AND CAN HARDLY COPE PSYCHOLOGICALLY WITH WHAT HE HAD EXPERIENCED. HE RECEIVED PSYCHOLOGICAL COUNSELLING IN HOSPITAL AND IS ALLOWED TO MAKE USE OF IT AGAIN WHEN HE WILL BE ADMITTED TO HOSPITAL FOR THE OPERATION. LVO NOTE: THE PATIENT IS 43 YEARS OLD AND CURRENTLY ON SICK LEAVE. HE ALLOWS FURTHER CONTACT REGARDING THE FOLLOW-UP ENQUIRY. HE WAS INFORMED ABOUT THE ANONYMISATION IN THE PV REPORTING SYSTEM AND WOULD LIKE TO HAVE ACCESS TO THE WRITTEN REPORT. THE EVENT IS ASSESSED AS SERIOUS AND NOT RECOVERED, THE EVENT IS RELATED TO OXYGEN, THE CAUSAL RELATEDNESS TO THE OXYGEN CYLINDER IS UNCLEAR. NO OFFICIAL NOTIFICATION WAS MADE. FOR DATA PROTECTION REASONS, IMAGES AND FINDINGS OF THE PATIENT WERE NOT SENT. THE DEVICES HAVE ALREADY BEEN RETRIEVED FROM THE PATIENT AND ARE IN QUARANTINE AT LINDE GMBH, AS CLAIMS ARE BEING MADE AS A PRODUCT LIABILITY CASE. PLEASE FIND ATTACHED THE LINDE GAS NOTIFICATION FORM WITH THE CURRENT DETAILS OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641011 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13261699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R