It was reported that nurse was getting an alert 52 (extended period of cold water) on the arctic sun device.Nurse stated the target temperature was 33 to 36c and this patient was set to 33c.Patient temperature was 34.7c, water temperature was 5.3c and flow rate was 3.1lpm.Patient started cooling yesterday, but they were unsure when.Cooling duration still read 24 hours.Patient weighed 100 kilograms.Nurse was unable to locate pad size, but confirmed they fit well.Mss discussed causes of heat generation.Nurse stated patient was sedated and paralyzed.There were no signs of infection.Patient was having seizure activity yesterday.Mss discussed benefits of counter warming and suggested discussing case with doctor to identify heat generation and whether target temperature was appropriate for this patient.Mss advised nurse to be diligent with skin checks.Nurse was just confirming there was nothing mechanically wrong with the device.
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The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue is inadequate pharmaceutical delivery to suppress shivering.However, this cannot be confirmed.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.It is unknown if the device met specifications and whether the device was influenced by the reported failure.The device was in use on a patient.The dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.Based on the results of the investigation, no additional actions are needed.The instructions for use were found adequate and state the following: "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." the information provided by bd represents all 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.
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It was reported that nurse was getting an alert 52 (extended period of cold water) on the arctic sun device.Nurse stated the target temperature was 33 to 36c and this patient was set to 33c.Patient temperature was 34.7c, water temperature was 5.3c and flow rate was 3.1lpm.Patient started cooling yesterday, but they were unsure when.Cooling duration still read 24 hours.Patient weighed 100 kilograms.Nurse was unable to locate pad size, but confirmed they fit well.Mss discussed causes of heat generation.Nurse stated patient was sedated and paralyzed.There were no signs of infection.Patient was having seizure activity yesterday.Mss discussed benefits of counter warming and suggested discussing case with doctor to identify heat generation and whether target temperature was appropriate for this patient.Mss advised nurse to be diligent with skin checks.Nurse was just confirming there was nothing mechanically wrong with the device.
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