BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 3760957 · Received April 11, 2014

    Report

    Report Number
    3002807968-2014-00014
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 12, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    PMA / PMN Number
    K093154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINT, THE TEMPERATURE OF THE SENSOR WAS SET TO 43 DEGREES CELSIUS AND THE SENSOR WAS RELOCATED EVERY 60 MINUTES. THIS IS WITHIN THE OPERATOR'S MANUAL FOR PATIENTS WITH NORMAL BLOOD CIRCULATION. HOWEVER, IN THE OPERATORS MANUAL THERE IS A WARNING ABOUT ALWAYS PAYING ATTENTION TO THE USE OF THE SENSORS ON PATIENTS IN SHOCK DUE TO RISK OF SKIN DAMAGE. WARNING - RISK OF SKIN DAMAGE. LONG-TERM HYPERTHERMIA MAY BLISTER SKIN. WHEN PRODUCING LOCAL HYPEREMIA BY MEANS OF HYPERTHERMIA, A CERTAIN RISK OF APPLYING TEMPERATURES HARMFUL TO THE SKIN IS ALWAYS PRESENT, ALTHOUGH THE RISK IS LIMITED DUE TO THE CONTROL SYSTEM OF THE INSTRUMENT. ALWAYS PAY ATTENTION TO THE USE OF HYPERTHERMIA FOR SPECIAL PATIENTS - E.G. PATIENTS IN SHOCK, PATIENTS WITH LOW BLOOD PRESSURE, AND PATIENTS WITH VASCULAR CONSTRICTIONS. THE PLACEMENT OF THE SENSOR FOR 60 MINUTES COULD EXPLAIN THE BURN MARK ON THIS PATIENT. TO ANALYZE THE CASE FURTHER THE SENSOR WILL BE INVESTIGATED TO SEE IF A PRODUCT MALFUNCTION ALSO CONTRIBUTED TO THIS CASE.

    Description of Event or Problem · 1

    THE PATIENT REC'D A SECOND DEGREE BURN MARK ON THE ARM, AFTER THE TC SENSOR WAS REMOVED. THE TEMPERATURE WAS SET TO 43 DEGREES CELSIUS, AND THE ELECTRODE WAS PLACED ON THE SAME LOCATION FOR 60 MINUTES. ACCORDING TO THE DOCTOR, THE PATIENT WAS GOING THROUGH A SEPTIC SHOCK, AND THIS CAN LEAD TO DECREASED BLOOD CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220571 TRANSCUTANEOUS BLOOD GAS MONITOR TCM TOSCA COMBI M LKD RADIOMETER MEDICAL APS TCM4 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 7.5 YR Other