BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR

    MDR report key: 20130966 · Received September 3, 2024

    Report

    Report Number
    3004972304-2024-00011
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    July 5, 2024
    Report Date
    November 19, 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. 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. NOTE: SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2010.

    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 2010. THE LIBERATOR STATIONARY LOX UNIT, PRODUCED IN 2010, WAS EVALUATED ACCORDING TO A PEER-REVIEWED TEST PROTOCOL. THE UNIT SHOWED SIGNS OF WEAR FROM USE AND MAINTENANCE, INCLUDING SCRATCHING ON THE DEWAR, A HEAVILY WORN METER BUTTON, AND DIRTY COMPONENTS. THERE WAS NO QUICK DISCONNECT VALVE (QDV) CLEANING KIT ATTACHED TO THE UNIT WHEN RECEIVED FOR THE INVESTIGATION, AND THE TOP FILL QUICK DISCONNECT VALVE CAP WAS MISSING. THESE LATTER TWO ITEMS ARE TYPICALLY ATTACHED TO THE UNIT VIA A CHAIN. THE UNIT ALSO SHOWED SIGNS OF DAMAGE BEYOND NORMAL USE. THE SHROUD WAS CRACKED NEAR THE ATTACHMENT POINT AND THE SCREW WAS MISSING. UNDER THE SHROUD, DEBRIS WAS FOUND IN THE UNIT, INCLUDING A SAFETY PIN AND POCKET LIGHTER. THE SIDE FILL QUICK DISCONNECT VALVE (QDV) WAS DAMAGED TO THE POINT OF UNSAFE USE FOR FILLING A PORTABLE LIQUID OXYGEN UNIT. THE DAMAGE COULD CAUSE A PORTABLE REFILL TO BECOME UN-CENTERED DURING FILLING, WHICH COULD POTENTIALLY LEAD TO LIQUID OXYGEN LEAK. THE ENGINEERING TEAM COULD NOT DETERMINE HOW THE DAMAGE TO THE SIDE FILL QDV OCCURRED AND WHETHER THE DAMAGE WAS PRESENT AT THE TIME OF THE EVENT OR OCCURRED DURING THE EVENT. BECAUSE OF THE DAMAGED SIDE FILL QDV, THE EVENT REPLICATION TEST WAS NOT ATTEMPTED WITH THE LIBERATOR UNIT. THE STROLLER PORTABLE LOX UNIT WAS EVALUATED ACCORDING TO A PEER-REVIEWED TEST PROTOCOL. THE EVENT REPLICATION TEST WAS CONDUCTED WITH A DIFFERENT LIBERATOR STATIONARY LIQUID OXYGEN BASE UNIT THAN THE ONE INVOLVED IN THE INCIDENT. THIS WAS DUE TO THE UNSAFE CONDITION OF THE LIBERATOR UNIT INVOLVED IN THE INCIDENT. NO LEAKS OR ANOMALIES WERE OBSERVED DURING THIS TEST. CAIRE WAS NOT ABLE TO REPLICATE THE EVENT. THE STROLLER UNIT HAD NORMAL WEAR ON THE QUICK DISCONNECT VALVE (QDV). NO DAMAGE WAS OBSERVED. IN TESTING, THE PORTABLE LOX UNIT'S PRIMARY RELIEF VALVE (PRV) AND SECONDARY RELIEF VALVE (SRV) OPENING PRESSURES WERE 2 PSI HIGHER THAN TEST SPECIFICATION. THIS IS STILL WITHIN SAFE OPERATING CONDITIONS FOR THE PORTABLE LOX UNIT AND IS NOT A CONTRIBUTING FACTOR TO INCIDENT. 1) THE INCIDENT OCCURRED AT THE QUICK DISCONNECT VALVE (QDV) OF THE STATIONARY LOX (SLOX) UNIT. 2) THE RELIEF VALVES ON THIS PORTABLE LOX UNIT HAVE NO PATHWAY TO THE SLOX QDV AND COULD NOT MECHANICALLY HAVE ANY CONNECTION TO THE INCIDENT. 3) THIS IS A PRESSURE RELIEF AND COULD NOT MECHANICALLY CAUSE ANY EXTERNAL LIQUID OXYGEN LEAK. ALL OTHER RESULTS WERE ACCEPTABLE AND SHOWED NO ANOMALIES. SLOX-RA-001 REV S WAS REVIEWED AND FOUND TO STILL BE ADEQUATE WITH NO UPDATE REQUIRED. USABILITY ANALYSIS LINE MAIN-3 ADDRESSES THE RISK OF DAMAGE TO THE UNIT WITHOUT PROPER PREVENTIVE MAINTENANCE. TOP DOWN ANALYSIS LINE TD-8 ADDRESSES USING THE QDV CLEANING KIT PRIOR TO USING THE CONNECTIONS. RISK CONTROL AND MITIGATIONS MEASURES INCLUDE REFERENCE TO PROPER CLEANING TECHNIQUE AND TOOLS IN THE USER AND SERVICE MANUALS.

    Description of Event or Problem · 0

    AS REPORTED: AFTER FILLING THE LPU, THE LOX LEAKED AND THEN FROZE COMPLETELY. THE WIFE OF THE PATIENT SOMEHOW FELL ON THE LBU (SHE CAN'T SAY HOW) AND GOT A COLD BURN ON HER KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701524 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13261701

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other