BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR

    MDR report key: 19726237 · Received July 11, 2024

    Report

    Report Number
    3004972304-2024-00006
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 26, 2024
    Report Date
    November 4, 2024
    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 INCIDENT AS DESCRIBED IS TYPICALLY CAUSED BY IMPROPER CLEANING OF THE VALVE, LEADING TO ICE BUILD UP HOLDING THE VALVE OPEN. 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.

    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. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2009.

    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. FOLLOW-UP INFORMATION FROM CAIRE DISTRIBUTOR VIVISOL HEIMBEHANDLUNGSGERÄTE GMBH'S INTERNAL INVESTIGATION REVEALED THAT THE PATIENT'S HUSBAND, NOT THE PATIENT WAS THE INJURED PARTY. THE PORTABLE LIQUID OXYGEN UNIT WAS REMOVED FROM THE BASE UNIT BY FORCE, CAUSING THE QUICK DISCONNECT VALVE TO BE TORN OUT. THE PATIENT'S HUSBAND SUFFERED MINOR CRYOGENIC BURNS TO HIS FINGERS. PROPERTY DAMAGE TO THE APARTMENT CAUSED BY THE ESCAPING OXYGEN WAS RECORDED IN PHOTOS. CAIRE'S ENGINEERING EVALUATION DETERMINED THAT THE LIBERATOR HAD SOME SCRATCHING ON THE DEWAR DUE TO NORMAL WEAR. THE QDVS ALSO HAD NORMAL WEAR. THE POP-OFF ASSEMBLY HAD DAMAGE THAT COULD BE FROM USE DAMAGE DUE TO AGE OR MISUSE. THERE WAS NO QDV CLEANING KIT ATTACHED TO THE UNIT DURING THE INVESTIGATION. ALL TESTING SECTIONS PASSED INCLUDING THE EVENT REPLICATION SECTION. UNDER PROPER USE CONDITIONS, CAIRE WAS NOT ABLE TO REPLICATE THE EVENT, AND THE POP-OFF ASSEMBLY DAMAGE CORRESPONDS WITH THE FOLLOW-UP INFORMATION PROVIDED BY VIVISOL. LIBERATOR RISK ASSESSMENT SLOX-RA-001 REV S WAS REVIEWED AND DEEMED STILL ADEQUATE WITHOUT REVISION. LIBERATOR USER MANUAL MN234-C4 INCLUDES INSTRUCTION ON PROPER CLEANING OF THE UNIT AND VALVES, AS WELL AS INSTRUCTION ON PROPER PROCEDURE FOR PLACING AND REMOVING A PORTABLE UNIT FROM THE BASE UNIT DURING THE FILLING PROCESS. LIBERATOR SERVICE MANUAL 13350704 ALSO INCLUDES INSTRUCTION ON PROPER CLEANING AND MAINTENANCE OF THE UNIT.

    Description of Event or Problem · 0

    AS REPORTED: LIQUID OXYGEN LEAKED OUT THROUGH A QUICK DISCONNECT VALVE THAT CAN NO LONGER BE CLOSED (TRANSFER VALVE TO PORTABLE UNIT). THE PATIENT SUFFERED MINOR CRYOGENIC BURNS TO HIS FINGERS. PROPERTY DAMAGE TO THE APARTMENT CAUSED BY THE ESCAPING OXYGEN WAS RECORDED IN PHOTOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385335 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13261728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention