BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 16751556 · Received April 17, 2023

    Report

    Report Number
    1018233-2023-02587
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 27, 2023
    Report Date
    August 8, 2023
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, BD HAS DETERMINED THAT THIS MDR EVENT IS NOT REPORTABLE. THE INFORMATION PROVIDED BY BD 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 BD.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT MET TARGETED TEMPERATURE AROUND 8:40AM AND NURSE STATED THERAPY HAD BEEN OVERSHOOTING IN ARCTIC SUN DEVICE. PATIENT CAME BACK UP AND THEN WENT TO 33.7C. 4 PADS WITH UNIVERSAL. NURSE DENIED SHIVERING, MICRO SHIVERING, AND SEIZURES. PATIENT HAD BEEN CONSISTENT HERE RECENTLY. TREND WAS THERMONEUTRAL. PATIENT TEMPERATURE WAS 32.4C, TARGETED TEMPERATURE WAS 33C, WATER TEMPERATURE WAS 25C. SYSTEM DIAGNOSTICS WAS OUTLET MONITOR TEMPERATURE (T1) WAS 26C, OUTLET CONTROL TEMPERATURE (T2) WAS 25.9C, INLET TEMPERATURE(T3) WAS 25.7C, CHILLER TEMPERATURE(T4) WAS 4.3C, WATER FLOW RATE (WFR) WAS 3.2 L/M, INLET PRESSURE (IP) WAS 7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 79 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 4, HEATER WAS 6 PERCENTAGE, SYSTEM HOURS WAS 3253, PUMP HOURS WAS 2706.1. DISCUSSED MEDICATION ADMINISTRATION. ADVISED TO CALL BACK IF WATER TEMPERATURE STARTS TO DROP AND PATIENT HAD NOT RISEN. DISCUSSED IMPORTANCE OF INVERSE RELATIONSHIP BETWEEN PATIENT TEMPERATURE AND WATER TEMPERATURE. PER CUSTOMER VIA PHONE ON 24APR2023, IT WAS REPORTED THAT THERAPY WAS COMPLETED AND THERE WAS NO IMPACT TO THE PATIENT. NURSE DID TROUBLESHOOTING WITH MIS AND WAS ADVISED TO USE AN EXTRA ABDOMINAL PAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT MET TARGETED TEMPERATURE AROUND 8:40AM AND NURSE STATED THERAPY HAD BEEN OVERSHOOTING IN ARCTIC SUN DEVICE. PATIENT CAME BACK UP AND THEN WENT TO 33.7C. 4 PADS WITH UNIVERSAL. NURSE DENIED SHIVERING, MICRO SHIVERING, AND SEIZURES. PATIENT HAD BEEN CONSISTENT HERE RECENTLY. TREND WAS THERMONEUTRAL. PATIENT TEMPERATURE WAS 32.4C, TARGETED TEMPERATURE WAS 33C, WATER TEMPERATURE WAS 25C. SYSTEM DIAGNOSTICS WAS OUTLET MONITOR TEMPERATURE (T1) WAS 26C, OUTLET CONTROL TEMPERATURE (T2) WAS 25.9C, INLET TEMPERATURE(T3) WAS 25.7C, CHILLER TEMPERATURE(T4) WAS 4.3C, WATER FLOW RATE (WFR) WAS 3.2 L/M, INLET PRESSURE (IP) WAS 7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 79 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 4, HEATER WAS 6 PERCENTAGE, SYSTEM HOURS WAS 3253, PUMP HOURS WAS 2706.1. DISCUSSED MEDICATION ADMINISTRATION. ADVISED TO CALL BACK IF WATER TEMPERATURE STARTS TO DROP AND PATIENT HAD NOT RISEN. DISCUSSED IMPORTANCE OF INVERSE RELATIONSHIP BETWEEN PATIENT TEMPERATURE AND WATER TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280279 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown Other