BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR

    MDR report key: 17950586 · Received October 17, 2023

    Report

    Report Number
    3004972304-2023-00013
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    August 24, 2023
    Report Date
    July 23, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. THE UNIT INVOLVED IN THE REPORTED EVENT IS IN CAIRE'S POSSESSION AT THE BALL GROUND, GA FACILITY AND IS PENDING ENGINEERING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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. **UDI RELATED DATA QUALITY UPDATES ONLY** SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2001.

    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 EVENT DESCRIPTION NOTED THAT THE UNIT WAS LEAKING DUE TO A RUPTURED BURST DISC, HOWEVER, CAIRE UNITS USE AN EVACUATION PLUG INSTEAD OF BURST DISCS. THE UNIT, MANUFACTURED IN 2001, WAS EXAMINED ACCORDING TO AN ENGINEERING PROTOCOL. THE UNIT'S EVACUATION PLUG WAS RELEASED DUE TO LOSS OF VACUUM. THE UNIT TESTING INCLUDED A VACUUM PULL AND HELIUM LEAK TEST. TESTING FOUND THAT THE INNER BOTTLE HAD A LEAK, BUT ONE SMALL ENOUGH THAT IT COULD NOT BE DETECTED BY THE HELIUM LEAK CHECK. THE AGE OF THE UNIT AND QUALITY OF MAINTENANCE OVER THAT TIME WAS DEEMED A CONTRIBUTING FACTOR, AS A SMALL LEAK IS POSSIBLE AFTER YEARS OF CUMULATIVE STRESS DURING THE LIFE OF THE VESSEL. IT WAS NOTED DURING TESTING THAT THE EVENT DATE WAS ONE DAY PRIOR TO THE SCHEDULED SERVICE AND PREVENTIVE MAINTENANCE DATE. THE STATIONARY LIQUID OXYGEN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ACCEPTABLE WITHOUT REVISION. THE UNIT WAS REPLACED.

    Description of Event or Problem · 0

    AS REPORTED: EMERGENCY RESPONSE TEAM WAS ACTIVATED OUT OF FAIRLESS HILLS ON THURSDAY (B)(6) 2023 AROUND 9 PM AT NIGHT TO RESPOND TO AN OX (B)(6) CONTAINER LEAKING AT A CUSTOMER.UPON ARRIVAL ONE OF THE CONTAINERS WAS FOUND TO HAVE A RUPTURED BURSTING DISC ON THE VACUUM CHAMBER OF THE CONTAINER, AND THREE OTHERS WERE RELEASING CONTENTS FROM THE 22 PSIG SAFETY ON THE CONTAINER.THE CONTAINER WITH THE BURSTING DISC FAILUREHAD LOST THE ENTIRE CONTENTS OF THE CONTAINER, 40 LITERS.THE CONTAINERS WERE FILLED EARLIER THAT DAY BY A DRIVER OUT OF THE LG&E NEWARK, NJ FACILITY. THERE WERE NO REPORTED INJURIES OR DAMAGE TO PROPERTY. LIQUID AND GASEOUS OXYGEN RELEASED TO THE ATMOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93584 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 10564184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown