BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCTIC SUN 5000

    MDR report key: 8350687 · Received February 19, 2019

    Report

    Report Number
    1018233-2019-00870
    Event Type
    Death
    Date Received
    February 19, 2019
    Date of Event
    December 15, 2018
    Report Date
    April 5, 2019
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM IS A THERMAL REGULATING SYSTEM, INDICATED FOR MONITORING AND CONTROLLING PATIENT TEMPERATURE IN ADULT AND PEDIATRIC PATIENTS OF ALL AGES. CAUTIONS THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM WILL MONITOR AND CONTROL PATIENT CORE TEMPERATURE BASED ON THE TEMPERATURE PROBE ATTACHED TO THE SYSTEM. THE CLINICIAN IS RESPONSIBLE FOR CORRECTLY PLACING THE TEMPERATURE PROBE AND VERIFYING THE ACCURACY AND PLACEMENT OF THE PATIENT PROBE AT THE START OF THE PROCEDURE. ¿ MEDIVANCE RECOMMENDS MEASURING PATIENT TEMPERATURE FROM A SECOND SITE TO VERIFY PATIENT TEMPERATURE. MEDIVANCE RECOMMENDS THE USE OF A SECOND PATIENT TEMPERATURE PROBE CONNECTED TO THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM TEMPERATURE 2 INPUT AS IT PROVIDES CONTINUOUS MONITORING AND SAFETY ALARM FEATURES. ALTERNATIVELY, PATIENT TEMPERATURE MAY BE VERIFIED PERIODICALLY WITH INDEPENDENT INSTRUMENTATION. THE RATE OF TEMPERATURE CHANGE AND POTENTIALLY THE FINAL ACHIEVABLE PATIENT TEMPERATURE IS AFFECTED BY MANY FACTORS. TREATMENT APPLICATION, MONITORING AND RESULTS ARE THE RESPONSIBILITY OF THE ATTENDING PHYSICIAN. IF THE PATIENT DOES NOT REACH TARGET TEMPERATURE IN A REASONABLE TIME OR THE PATIENT IS NOT ABLE TO BE MAINTAINED AT THE TARGET TEMPERATURE, THE SKIN MAY BE EXPOSED TO LOW OR HIGH WATER TEMPERATURES FOR AN EXTENDED PERIOD OF TIME WHICH MAY INCREASE THE RISK FOR SKIN INJURY. ENSURE THAT PAD SIZING/COVERAGE AND CUSTOM PARAMETER SETTINGS ARE CORRECT FOR THE PATIENT AND TREATMENT GOALS, WATER FLOW IS GREATER THAN OR EQUAL TO 2.3 LITERS PER MINUTE AND THE PATIENT TEMPERATURE PROBE IS IN THE CORRECT PLACE. FOR PATIENT COOLING, ENSURE ENVIRONMENTAL FACTORS SUCH AS EXCESSIVELY HOT ROOMS, HEAT LAMPS, AND HEATED NEBULIZERS ARE ELIMINATED AND PATIENT SHIVERING IS CONTROLLED. OTHERWISE, CONSIDER INCREASING MINIMUM WATER TEMPERATURE, MODIFYING TARGET TEMPERATURE TO AN ATTAINABLE SETTING OR DISCONTINUING TREATMENT. FOR PATIENT WARMING, CONSIDER DECREASING MAXIMUM WATER TEMPERATURE, MODIFYING TARGET TEMPERATURE TO AN ATTAINABLE SETTING OR DISCONTINUING TREATMENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT¿S TEMPERATURE WAS READING 97.5F WITH A TEMPERATURE SENSING FOLEY CATHETER WHILE RECEIVING THERAPY ON AN ARCTIC SUN DEVICE. THE PATIENT FELT WARMER TO THE TOUCH, SO THE TEMPERATURE SENSING FOLEY CATHETER WAS REPLACED AND THE PATIENT¿S TEMPERATURE READ 106.5F. THE PATIENT WAS GIVEN ICED NORMAL SALINE, TYLENOL, AND ANTIBIOTICS. THE PATIENT WAS PRONOUNCED BRAIN DEAD. THE PATIENT HAD BEEN ADMITTED FOR AN INTRAPARENCHYMAL HEMORRHAGE. IT WAS ALSO MENTIONED THAT THE ARCTIC SUN DEVICE HAD BEEN FILLED WITH HOT WATER INSTEAD OF COLD WATER. NO CONTACT INFORMATION WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S TEMPERATURE WAS READING 97.5F WITH A TEMPERATURE SENSING FOLEY CATHETER WHILE RECEIVING THERAPY ON AN ARCTIC SUN DEVICE. THE PATIENT FELT WARMER TO THE TOUCH, SO THE TEMPERATURE SENSING FOLEY CATHETER WAS REPLACED AND THE PATIENT¿S TEMPERATURE READ 106.5F. THE PATIENT WAS GIVEN ICED NORMAL SALINE, TYLENOL, AND ANTIBIOTICS. THE PATIENT WAS PRONOUNCED BRAIN DEAD. THE PATIENT HAD BEEN ADMITTED FOR AN INTRAPARENCHYMAL HEMORRHAGE. IT WAS ALSO MENTIONED THAT THE ARCTIC SUN DEVICE HAD BEEN FILLED WITH HOT WATER INSTEAD OF COLD WATER. NO CONTACT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142536 ARCTIC SUN 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 Death