BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC SUN 5000

    MDR report key: 10733049 · Received October 26, 2020

    Report

    Report Number
    10733049
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    April 14, 2020
    Report Date
    June 1, 2020
    Manufacturer
    MEDIVANCE, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    PATIENT NOTED TO HAVE BACK AND THIGH WOUNDS WITH A MIXTURE OF SUPERFICIAL AND DEEP PARTIAL THICKNESS, AND AN AREA OF FULL THICKNESS BURN TO THE LEFT LOWER BACK, SECONDARY TO USE OF ARCTIC SUN WARRANTING TRANSFER TO A BURN UNIT. FROM PATIENT INFO: THE PATIENT IS A MIDDLE-AGED MALE WITH A HISTORY OF EPILEPSY OF UNCLEAR ETIOLOGY, ALCOHOL ABUSE, FREQUENT HISTORY OF WITHDRAWAL SEIZURES, HYPERTENSION, AND MULTIPLE SCLEROSIS (NOT ON DISEASE MODIFYING THERAPY), HE WAS TRANSFERRED TO NEURO ICU DUE TO CONCERN FOR SUBCLINICAL STATUS EPILEPTICUS. HE WAS FOUND TO BE COVID+. HIS HOSPITAL COURSE WAS COMPLICATED BY HYPOXIC RESPIRATORY FAILURE AND INTRACTABLE FEVERS. HE WAS PLACED ON THE ARCTIC SUN DEVICE TO MAINTAIN NORMOTHERMIA 4 DAYS LATER. THERAPY WAS INITIATED USING THE ARCTIC SUN, HOWEVER TARGET TEMPERATURE OF 37 DEGREES CELSIUS WAS NOT REACHED DURING TREATMENT. THE TEMPERATURE OF THE PATIENT CONTINUED TO STAY WELL ABOVE TARGET TEMPERATURE, WHILE THE WATER TEMPERATURE ON THE ARCTIC SUN STAYED LOW (RANGING FROM 5-12 DEGREES CELSIUS) FOR ALMOST THREE DAYS OF TREATMENT. IN NORMAL CIRCUMSTANCES, THE DEVICE WATER TEMPERATURE WILL OSCILLATE TO MAINTAIN THE PATIENT'S TEMPERATURE AT THE DESIRED SETTING. THE DEVICE MAY HAVE DIPS TO COLDER WATER TEMPERATURES, BUT WILL COME BACK UP AS THE PATIENT RESPONDS. IN THIS CASE, THE PATIENT NEVER RESPONDED TO CUTANEOUS TEMPERATURE MANAGEMENT. SKIN CHECKS WERE COMPLETED BY THE NURSING TEAM, AND BLISTERS WERE NOTED TO FORM A WEEK LATER. TREATMENT WAS THEN TERMINATED THE FOLLOWING DAY. THE BLISTERS CONTINUED TO EVOLVE OVER THE HOSPITAL STAY RESULTING IN SUBCUTANEOUS THERMAL DAMAGE FROM THE COLD TEMPERATURES, AND THE PATIENT HAD TO BE TRANSFERRED FOR SPECIALIZED BURN TREATMENTS. IT IS WITH CAUTION THAT WE UTILIZE CUTANEOUS TEMPERATURE REGULATORY MANAGEMENT FOR OUR COVID PATIENTS, GIVEN THE ASSOCIATED RISK OF MICROTHROMBI AFFECTING MULTIPLE ORGANS INCLUDING SKIN. IT IS UNKNOWN WHETHER THE RESPONSE TO COLD WATER TEMPERATURES WAS MAGNIFIED BY THE DISEASE PROCESS. WE STRONGLY URGE WE MAINTAIN VIGILANCE WHEN UTILIZING ARCTIC SUN ON COVID+ PATIENTS FOR TEMPERATURE MANAGEMENT.

    Description of Event or Problem · 1

    PATIENT NOTED TO HAVE BACK AND THIGH WOUNDS WITH A MIXTURE OF SUPERFICIAL AND DEEP PARTIAL THICKNESS, AND AN AREA OF FULL THICKNESS BURN TO THE LEFT LOWER BACK, SECONDARY TO USE OF ARCTIC SUN WARRANTING TRANSFER TO A BURN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197410 ARCTIC SUN 5000 SYSTEM, THERMAL REGULATING DWJ MEDIVANCE, INC. 50000000

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Hospitalization| R