BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC SUN 5000

    MDR report key: 11895693 · Received May 27, 2021

    Report

    Report Number
    1018233-2021-03072
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 4, 2021
    Report Date
    August 18, 2021
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS USER RELATED DUE TO THE OVERFILLING OF THE RESERVOIR. THE DEVICE DID NOT MEET SPECIFICATIONS AND WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS IN USE ON A PATIENT. 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 IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. REFILL THE RESERVOIR. FROM THE HYPOTHERMIA THERAPY SCREEN OR THE NORMOTHERMIA THERAPY SCREEN, PRESS THE FILL RESERVOIR BUTTON. THE FILL RESERVOIR SCREEN WILL APPEAR. FOLLOW THE DIRECTIONS ON THE SCREEN. ADD ONE VIAL OF ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM CLEANING SOLUTION TO THE FIRST BOTTLE OF DISTILLED OR STERILE WATER. THE FILLING PROCESS WILL AUTOMATICALLY STOP WHEN THE RESERVOIR IS FULL. CONTINUE TO REPLACE THE BOTTLES OF STERILE OR DISTILLED WATER UNTIL THE FILLING PROCESS STOPS. WHEN THE FILL RESERVOIR PROCESS IS COMPLETE, THE SCREEN WILL CLOSE." CORRECTION: F. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT REWARMING. PATIENT TEMPERATURE WAS 34.6C, TARGET TEMPERATURE WAS 37C, WATER TEMPERATURE WAS 15.6C, FLOW RATE WAS 2.8 L/M. THEY DENIED ANY ALERTS OR ALARMS. PATIENT WAS NOT ON CONTINUOUS RENAL REPLACEMENT THERAPY. GOOD PAD COVERAGE WITH NO EXPOSED ABDOMEN. TDI 4 BARS TRENDING DOWNWARD. PATIENT ON CONTINUOUS DRIP OF FENTANYL AND VERSED. ALSO RECEIVING VASOPRESSORS. MSS WALKED THROUGH PLACING DEVICE IN MANUAL CONTROL AT 42C. T1 WAS 29.6C, T2 WAS 29.6C, T3 WAS 26.5C, T4 WAS 4.8C. WATER FLOW RATE WAS 3.0 L/M. INLET PRESSURE WAS -6.9PSI. CIRCULATION PUMP COMMAND WAS 68%. MIXING PUMP COMMAND WAS 0%. HEATER WAS 100%. SYSTEM HOURS WERE 3492.2, PUMP HOURS WERE 3292.9. THEY DISABLED MANUAL CONTROL AND DRAINED WATER FROM RIGHT DRAIN PORT. WATER ROSE TO 31.7C, PATIENT TEMPERATURE WAS 34.3C, FLOW RATE WAS 2.7 L/M AND TDI NOW ONLY 3 BARS TRENDING DOWNWARD. DOCTOR DISCUSSED ADDING BLANKETS TO HEAD, HANDS AND FEET OR BAIR HUGGER. DOCTOR CALLED BACK AT 12:39PM ET. PATIENT TEMPERATURE WAS 33.9C AND WATER TEMPERATURE WAS 37.6C. DOCTOR HAD DRAIN MORE WATER OFF OF THE RIGHT DRAIN PORT. THEY INCREASED HIGH WATER LIMIT FROM 40C TO 42C. WATER TEMPERATURE WAS 37.6C AND FLOW RATE WAS 3.2 L/M. DOCTOR ADVISED AGAIN TO ADD BLANKETS OR BAIR HUGGER AND INCREASE ROOM TEMP.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS NOT REWARMING. PATIENT TEMPERATURE WAS 34.6C, TARGET TEMPERATURE WAS 37C, WATER TEMPERATURE WAS 15.6C, FLOW RATE WAS 2.8 L/M. THEY DENIED ANY ALERTS OR ALARMS. PATIENT WAS NOT ON CONTINUOUS RENAL REPLACEMENT THERAPY. GOOD PAD COVERAGE WITH NO EXPOSED ABDOMEN. TDI 4 BARS TRENDING DOWNWARD. PATIENT ON CONTINUOUS DRIP OF FENTANYL AND VERSED. ALSO RECEIVING VASOPRESSORS. MSS WALKED THROUGH PLACING DEVICE IN MANUAL CONTROL AT 42C. T1 WAS 29.6C, T2 WAS 29.6C, T3 WAS 26.5C, T4 WAS 4.8C. WATER FLOW RATE WAS 3.0 L/M. INLET PRESSURE WAS -6.9PSI. CIRCULATION PUMP COMMAND WAS 68%. MIXING PUMP COMMAND WAS 0%. HEATER WAS 100%. SYSTEM HOURS WERE 3492.2, PUMP HOURS WERE 3292.9. THEY DISABLED MANUAL CONTROL AND DRAINED WATER FROM RIGHT DRAIN PORT. WATER ROSE TO 31.7C, PATIENT TEMPERATURE WAS 34.3C, FLOW RATE WAS 2.7 L/M AND TDI NOW ONLY 3 BARS TRENDING DOWNWARD. DOCTOR DISCUSSED ADDING BLANKETS TO HEAD, HANDS AND FEET OR BAIR HUGGER. DOCTOR CALLED BACK AT 12:39PM ET. PATIENT TEMPERATURE WAS 33.9C AND WATER TEMPERATURE WAS 37.6C. DOCTER HAD DRAIN MORE WATER OFF OF THE RIGHT DRAIN PORT. THEY INCREASED HIGH WATER LIMIT FROM 40C TO 42C. WATER TEMPERATURE WAS 37.6C AND FLOW RATE WAS 3.2 L/M. DOCTOR ADVISED AGAIN TO ADD BLANKETS OR BAIR HUGGER AND INCREASE ROOM TEMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794388 ARCTIC SUN 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention