BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 1000

    MDR report key: 8668530 · Received June 4, 2019

    Report

    Report Number
    3004972304-2019-00036
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 4, 2019
    Report Date
    July 14, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K861503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS ALREADY BEEN REPAIRED BY THE DISTRIBUTOR. IT WAS ORIGINALLY DETERMINED THAT UNAUTHORIZED HEAT EXCHANGER MODIFICATIONS RESULTED IN INSUFFICIENT HEAT EXCHANGE ALLOWING LIQUID OXYGEN TO EXIT THE UNIT WITHOUT BEING VAPORIZED. UPON ADDITIONAL INVESTIGATION, IT WAS DISCOVERED THAT THE HEAT EXCHANGER OBSERVED ON THE UNIT WAS A DEVICE DESIGN PRODUCED FROM 1984 TO 1989 FOR THE COMPANION 1000. THIS HEAT EXCHANGER DESIGN HAS AN INSUFFICIENT CAPACITY FOR FLOW RATES OF 6 LPM. THERE IS A POTENTIAL FOR LIQUID OXYGEN TO BE DELIVERED TO THE PATIENT WHEN USING A FLOW RATE OF 6 LPM. THE EXPECTED SERVICE LIFE OF THE COMPANION 1000 PORTABLE LOX UNIT IS 5 YEARS. DUE TO THE MANUFACTURING DATE OF THE AFFECTED UNITS, SHIPPING RECORDS ARE NOT AVAILABLE. A MARKET WITHDRAWAL WILL BE PERFORMED. ALL CURRENT CAIRE COMPANION 1000 LIQUID OXYGEN CUSTOMERS WILL BE NOTIFIED OF THE DESIGN ISSUE AND WILL BE INSTRUCTED TO REVIEW THEIR C1000 INVENTORY TO IDENTIFY ANY AFFECTED PRODUCT. CAIRE WILL REQUEST THE RETURN OF ANY AFFECTED C1000 UNITS FOR REPAIR OR REPLACEMENT.

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS ALREADY BEEN REPAIRED BY THE DISTRIBUTOR. UNAUTHORIZED HEAT EXCHANGER MODIFICATIONS RESULTED IN INSUFFICIENT HEAT EXCHANGE ALLOWING LIQUID OXYGEN TO EXIT THE UNIT WITHOUT BEING VAPORIZED.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED FOR AN EVALUATION; HOWEVER, IT HAS ALREADY BEEN REPAIRED BY THE DISTRIBUTOR. THEY STATED THEY WERE UNABLE TO DUPLICATE THE ISSUE. MULTIPLE NER TEST RESULTS PROVED THE VACUUM TO BE GOOD UPON ARRIVAL. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP MDR WILL BE REPORTED.

    Description of Event or Problem · 1

    LIQUID OXYGEN GOT INTO THE CANNULA. CUSTOMER DOES NOT HAVE SPECIFICS AS TO THE EXTENT OF THE PATIENT'S INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460184 COMPANION 1000 UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. B-775099-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization