BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPANION 1000

    MDR report key: 10755959 · Received October 29, 2020

    Report

    Report Number
    3004972304-2020-00031
    Event Type
    Death
    Date Received
    October 29, 2020
    Date of Event
    July 23, 2019
    Report Date
    February 25, 2021
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K861503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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.". THE DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE C1000 UNIT IN QUESTION WAS FOUND TO POSSESS BOTH A HIGH PNER AND A SHORT HEAT EXCHANGER. EITHER OF THESE CONDITIONS CAN ALLOW VERY COLD GASEOUS OXYGEN OR LIQUID OXYGEN TO ENTER THE CANNULA. EXPOSURE TO COLD GASES OR LIQUIDS WOULD FROST THE CANNULA DURING PROLONGED PERIODS OF USE. A MARKET WITHDRAWAL IS BEING PERFORMED FOR COMPANION (B)(4) DEVICES PRODUCED FROM 1984 TO 1989. THE 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. ALL CURRENT CAIRE COMPANION 1000 LIQUID OXYGEN CUSTOMERS HAVE BEEN NOTIFIED OF THE DESIGN ISSUE AND WERE INSTRUCTED TO REVIEW THEIR C1000 INVENTORY TO IDENTIFY ANY AFFECTED PRODUCT. CAIRE HAS REQUESTED THE RETURN OF ANY AFFECTED C1000 UNITS FOR REPAIR OR REPLACEMENT.

    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 HAS NOT BEEN RETURNED TO CAIRE FOR AN EVALUATION. ADDITIONAL INFORMATION ABOUT THE INCIDENT WAS RECEIVED FROM THE CUSTOMER: A NURSING FACILITY NOTIFIED THE CUSTOMER OF THE INCIDENT. THE NURSING FACILITY STATED THAT THE PATIENT'S LIQUID OXYGEN PORTABLE UNIT HAD MALFUNCTIONED, CAUSING THE NASAL CANNULA TO BECOME FROZEN TO THE PATIENT'S FACE. THEY ALSO DESCRIBED A WHITE VAPOR COMING FROM THE PATIENT'S MOUTH AND A WHITE VAPOR SPRAYING OUT OF THE TOP OF THE UNIT. THE PATIENT'S LITER FLOW WAS SET AT 6LPM CONTINOUS, AND THE PATIENT WAS UTILIZING A TRADITIONAL 7' NASAL CANNULA. THE CUSTOMER RETRIEVED THE UNIT FROM THE NURSING FACILITY AND TESTED IT ON THREE SEPARATE OCCASIONS BY FILLING IT WITH LIQUID OXYGEN AND ALLOWING IT TO RUN FREELY AT 6LPM THROUGH A TRADITIONAL 7' NASAL CANNULA. THE UNIT FUNCTIONED NORMALLY WITH NO ISSUES OR ANOMALIES NOTED, AND THEY COULD NOT DUPLICATE THE PROBLEM. NO INVASIVE OR DESTRUCTIVE TESTING WAS PERFORMED ON THE UNIT. THE UNIT WAS TAKEN OUT OF SERVICE AT THAT TIME AND HAS BEEN HELD IN STORAGE EVER SINCE. A MARKET WITHDRAWAL IS BEING PERFORMED FOR COMPANION (B)(4) DEVICES PRODUCED FROM (B)(4) TO (B)(4) . THE 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. ALL CURRENT CAIRE COMPANION 1000 LIQUID OXYGEN CUSTOMERS HAVE BEEN NOTIFIED OF THE DESIGN ISSUE AND WERE INSTRUCTED TO REVIEW THEIR C1000 INVENTORY TO IDENTIFY ANY AFFECTED PRODUCT. CAIRE HAS REQUESTED THE RETURN OF ANY AFFECTED (B)(4) UNITS FOR REPAIR OR REPLACEMENT.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS NOT BEEN RETURNED TO CAIRE FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE NASAL CANNULA BECAME FROZEN TO THE PATIENT. THE PATIENT WAS IN HOSPICE. THE PATIENT DIED MANY DAYS LATER, BUT THE PROVIDER STATED THAT IT WAS NOT RELATED TO THE INCIDENT. THE PROVIDER TESTED THE UNIT, BUT THE FAULT WAS NOT DUPLICATED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220250 COMPANION 1000 UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. B-775099-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death