BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR

    MDR report key: 17030962 · Received May 31, 2023

    Report

    Report Number
    3004972304-2023-00010
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    March 30, 2023
    Report Date
    September 20, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE LIBERATOR 45 UNIT WAS EVALUATED AT CAIRE'S LANGENFELD, GERMANY FACILITY. THE UNIT SHOWED NO SIGNS OF MAJOR DAMAGE; HOWEVER, SIGNS OF DAMAGE WERE PRESENT TO THE TOP FILL QUICK DISCONNECT VALVE (QDV) AND THE SHROUD CONSISTENT WITH NORMAL WEAR DAMAGE OVER THE LIFE OF THE UNIT. THE PROBLEM AS STATED IN THE EVENT WAS REPLICATED, BUT LITTLE LIQUID WAS RELEASED. THE BOTTLE AND QDV ON THE UNIT WERE PRODUCED IN 2009. THE QDV ON THE UNIT SHOWED SIGNS OF WEAR AND APPEARED TO NEED MAINTENANCE. PROBABLE ROOT CAUSE CAN BE TRACED TO THE QDV BEING OPEN SLIGHTLY, LIKELY CAUSED BY DIRT IN THE VALVE AND FREEZING AND/OR WEAR. PER THE TECHNICAL SERVICE MANUAL (PN 13350704 REV L), MAINTENANCE SHOULD BE CONDUCTED BY THE HOME HEALTH CARE DISTRIBUTOR FOR ANY SIGNS OF DAMAGED OR MALFUNCTIONING PARTS. THE UNIT WAS IN WORKING CONDITION AND PASSED NORMAL FUNCTIONAL TESTING OTHERWISE. THIS CASE WILL BE REVIEWED IN POST-MARKET SURVEILLANCE. THE LOX BASE UNIT RISK ASSESSMENT, SLOX-RA-001 REV R, WAS REVIEWED AND DETERMINED TO BE ADEQUATE WITHOUT REVISION.

    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

    A NURSE RECEIVED A LIQUID OXYGEN BURN ON THE HAND WHILE FILLING A MOBILE LOX UNIT FROM THE LIBERATOR BASE UNIT. AT THE END OF THE FILLING PROCESS LOX LEAKED FROM THE QUICK DISCONNECT VALVE ONTO THE NURSE'S HAND. THE NURSE STILL HAD VISIBLE LESIONS AND NUMBNESS IN THE AFFECTED AREAS AND THE INJURY WAS STILL BEING TREATED AT THE TIME OF REPORTING. HIS DOCTOR TOLD HIM THE FEELING SHOULD RETURN IN THE COMING MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029742 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13261701

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other