BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR

    MDR report key: 24815752 · Received April 8, 2026

    Report

    Report Number
    3004972304-2026-00003
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    October 9, 2025
    Report Date
    April 8, 2026
    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. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2015. THE SIDE FILL QDV-TO-MANIFOLD CONNECTION SHOWED SIGNS OF DAMAGE DUE TO ROUGH HANDLING, WHICH LED TO A LOX LEAK AND ICING ON THE UNIT. THESE CONDITIONS CAN IMPACT THE EFFICIENCY OF THE UNIT, WHICH CAN CAUSE OXYGEN GAS DELIVERY TO BE TOO COLD. THIS IS DOCUMENTED IN CAIRE'S RISK ASSESSMENT. 1. FAILURE TO CLEAN MOISTURE FROM THE QDVS PRIOR TO FILLING A PORTABLE UNIT FROM A RESERVOIR (BASE UNIT) CAN CAUSE THE TWO UNITS TO FREEZE TOGETHER. 2. ATTEMPTING TO REMOVE A PORTABLE UNIT FROM A RESERVOIR (BASE UNIT) WHEN THEY ARE FROZEN TOGETHER WILL AFFECT THE QDV-TO-MANIFOLD CONNECTION AND CAN CAUSE A LEAK. THE DEVICE IFU INSTRUCTS USERS TO ALWAYS CLEAN AND DRY THE QDVS BEFORE FILLING A PORTABLE UNIT FROM A RESERVOIR (BASE UNIT). THE USER IS ALSO INSTRUCTED NOT TO FORCE APART PORTABLE AND BASE UNITS THAT ARE FROZEN TOGETHER, AND TO STOP USING THE UNIT IF A LEAK IS PRESENT. CAIRE SUPPLIES A MICROFIBER CLOTH AND SWAB CLEANING KIT FOR THE PURPOSE OF CLEANING AND DRYING THE QDV, HOWEVER, ANY MICROFIBER CAN BE USED. THE USER MANUAL PROVIDES INSTRUCTIONS ON THE PROPER CLEANING AND DRYING OF THE QDV. LIBERATOR RISK ASSESSMENT SLOX-RA-001 REV U WAS REVIEWED AND DEEMED ADEQUATE WITHOUT REVISION. LOX LEAKAGE DUE TO A LEAK IN THE QDV TO MANIFOLD TUBE CONNECTION AND THE POTENTIAL EFFECTS OF THE COLD DELIVERY OF OXYGEN ARE ADDRESSED IN THE TOP DOWN ANALYSIS AND DFMECA. PATIENTS ARE INSTRUCTIONED TO CEASE USE OF ANY DEVICE SHOWING SIGNS OF EXCESSIVE ICING OR LEAK, AND SWITCH TO A BACKUP OXYGEN SOURCE.

    Description of Event or Problem · 0

    AS REPORTED: THE PATIENT IS REGULARLY SUPPLIED WITH LIQUID OXYGEN BY VIVISOL. DURING THE NIGHT FROM ((B)(6) 2025) TO (B)(6), THE PATIENT USED THE AFFECTED CYLINDER FOR THE FIRST TIME. SEVERE ICE FORMATION APPEARED OVER THE ENTIRE CYLINDER. THE ESCAPING OXYGEN WAS EXTREMELY COLD, WHICH CAUSED THE PATIENT'S BRONCHI TO CONSTRICT IMMEDIATELY. AS A RESULT, HE WAS NO LONGER RECEIVING SUFFICIENT OXYGEN. WITHIN A VERY SHORT TIME, HIS OXYGEN SATURATION DROPPED TO 35%, HE DEVELOPED ACUTE SHORTNESS OF BREATH AND COLLAPSED. THE EMERGENCY DOCTOR WAS CALLED BY RELATIVES. THE PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE. HE WAS HOSPITALIZED; CURRENTLY, THE PATIENT IS BACK HOME AND IS AGAIN BEING SUPPLIED WITH LOX. COLLECTION OF THE AFFECTED BU AND SHIPMENT TO THE TECHNICAL DEPARTMENT. INCOMING INSPECTION BY OUR [VIVISOL] TECHNICAL TEAM - RESULT: THE DEVICE ARRIVED PARTIALLY FILLED WITH LOX, PRESSURE TEST PASSED, NO VISIBLE OR AUDIBLE OXYGEN LEAKAGE, NO APPARENT DENTS OR DAMAGE; THE BU SHOWS NO DEFECT AND HAS PASSED ALL TESTS SUCCESSFULLY. LEAK TEST AND PROBE MEASUREMENT ARE ONLY POSSIBLE AFTER DISASSEMBLING THE DEVICE. HOWEVER, SINCE THE PRESSURE AND NER TESTS WERE POSITIVE, THE LEAK TEST WOULD LIKELY ALSO BE POSITIVE. NOTIFICATION OF THE SERIOUS INCIDENT TO THE COMPETENT AUTHORITY (AGES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876483 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC 13261728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization