BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 19735312 · Received July 12, 2024

    Report

    Report Number
    3004972304-2024-00007
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    April 7, 2024
    Report Date
    September 17, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO (B)(6) FACILITY FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION. THE DISTRIBUTOR NOTIFIED CAIRE THAT THE LIQUID OXYGEN BASE UNIT (LIBERATOR) NOTED IN THE INCIDENT DESCRIPTION IS NOT AVAILABLE FOR EVALUATION AND THE SERIAL NUMBER IS NOT KNOWN.

    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 2007. THE UNIT, MANUFACTURED IN 2007 AND IN THE FIELD SINCE THAT TIME, WAS RETURNED TO CAIRE GERMANY WITH DAMAGE TO THE OUTSIDE CASING AND THE VENT VALVE NOT IN ITS NORMAL POSITION THAT CAIRE SHIPS A UNIT. THE VENT VALVE SITS OUTSIDE THE CASE RESTING IN THE INDENT. THE QDV WAS ALSO NOT ALIGNED AND CAUSED A LEAK OUT OF THE CONNECTION. THIS LEAK CAUSED THE PRESSURE RETENTION TEST TO FAIL AND LED TO THE SUBSEQUENT SECTIONS NOT BEING TESTED. THE OBSERVED DAMAGE AND NON-STANDARD CONFIGURATION OF THE STROLLER PORTABLE LIQUID OXYGEN UNIT WAS NOT REPRESENTATIVE OF CAIRE PORTABLE LIQUID OXYGEN UNITS AS THEY SHIP FROM CAIRE'S MANUFACTURING FACILITY, AND NOT REPRESENTATIVE OF NORMAL WEAR AND TEAR FOR AN AGED UNIT IN THE FIELD. THERE IS CURRENTLY NO EVIDENCE OF A TREND AND EVIDENCE OF IMPROPER MAINTENANCE APPEARS TO BE ISOLATED TO ONE UNIT. THE LIQUID OXYGEN BASE UNIT INVOLVED IN THE INCIDENT WAS LOST BY THE DISTRIBUTOR AND COULD NOT BE EVALUATED BY THE MANUFACTURER. RETRAINING OF THIRD-PARTY SERVICE PERSONNEL TOOK PLACE ON SITE AT THE AUSTRIAN SERVICE FACILITY IN JULY 2024, CONDUCTED BY CAIRE SERVICE MANAGEMENT PERSONNEL. STROLLER PORTABLE LIQUID OXYGEN UNIT RISK ASSESSMENT PLOX-RA-002, REV M WAS REVIEWED AND FOUND TO BE STILL ADEQUATE WITHOUT REVISION. THE MAINTENANCE SECTION OF THE USABILITY ASSESSMENT ADDRESSES THIRD-PARTY SERVICERS IMPROPERLY MAINTAINING AND SERVICING A UNIT, AND POTENTIAL ADVERSE OUTCOMES. MITIGATION FACTORS INCLUDE INSTRUCTIONS FOR PROPER MAINTENANCE AND CONFIGURATION OF THE UNIT FOUND IN THE SERVICE MANUAL.

    Description of Event or Problem · 0

    AS REPORTED A NURSE FILLED THE LPU, WHEN THE LPU WAS FULL, IT WAS NO LONGER POSSIBLE TO CLOSE THE VENT VALVE. AS A RESULT, BOTH VESSELS EMPTIED. THE FIRE BRIGADE WAS CALLED. THE FIRE BRIGADE CARRIED OUT AN OXYGEN MEASUREMENT AND FOUND A CONCENTRATION OF 24.5%. THEY OPENED THE WINDOWS AND ALSO VENTILATED THE ROOM USING MECHANICAL VENTILATION. UNFORTUNATELY, ONE OF THE FIREFIGHTERS BURNED HIS HAND WITH LOX. (ACCORDING TO THE FIRE BRIGADE, THEY WERE NOT PREPARED AND DID NOT HAVE COLD GLOVES). THE PATIENT AND NURSE SUFFERED NO INJURIES. THE CONCERNED LPU IS ALREADY IN SCHWECHAT IN OUR HQ AND WE CAN PROVIDE IT FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979715 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 10845200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention