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It was reported that the hypothermia patient was rewarming on the (b)(6) device.The nurse was confused and had been changing settings.The nurse stated that the patient should have started rewarming at 9:40 am but the arctic sun device already started rewarming around 4:00 am.The patient temperature was 33.8c, the water temperature was 23c, flow rate was 2.7l/min and the target temperature was 33c for cooling.Mss explained to nurse that the arctic sun device was set to start rewarming automatically and the 24-hour cooling clock was to start at target.The rewarming showed rewarm from 33.7c at 0.25c/ hour to 36.4c.Mss asked why they were not rewarming to 37c, and nurse changed it.Mss asked for a screen shot.The patient was below the target temperature (31c-32c range) when cooling was started.The rewarming started as little after 4 am and the patient¿s temperature was 34c, so the (b)(6) device cooled the patient temperature to 33c.The device was also stopped around 6 am.The nurse was not sure who stopped the device.Mss discussed how the device was set up and encouraged the nurse not to change settings randomly.Mss explained that rewarm started after the 24 hours of cooling unless someone decreased the cooling time.The patient was above the 33c cooling target when rewarming started so the device cooled the patient back to 33c and was rewarming from 33c.The nurse stated that the patient had been shivering so they administered a paralytic recently.The trend shows 1 arrow down.The device was responding appropriately to changes in the patient temperature.Mss encouraged the nurse to continue to treat any heat generation.
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It was reported that the hypothermia patient was rewarming on the arctic sun device.The nurse was confused and had been changing settings.The nurse stated that the patient should have started rewarming at 9:40 am but the arctic sun device already started rewarming around 4:00 am.The patient temperature was 33.8c, the water temperature was 23c, flow rate was 2.7l/min and the target temperature was 33c for cooling.Mss explained to nurse that the arctic sun device was set to start rewarming automatically and the 24-hour cooling clock was to start at target.The rewarming showed rewarm from 33.7c at 0.25c/ hour to 36.4c.Mss asked why they were not rewarming to 37c, and nurse changed it.Mss asked for a screen shot.The patient was below the target temperature (31c-32c range) when cooling was started.The rewarming started as little after 4 am and the patient¿s temperature was 34c, so the arctic sun device cooled the patient temperature to 33c.The device was also stopped around 6 am.The nurse was not sure who stopped the device.Mss discussed how the device was set up and encouraged the nurse not to change settings randomly.Mss explained that rewarm started after the 24 hours of cooling unless someone decreased the cooling time.The patient was above the 33c cooling target when rewarming started so the device cooled the patient back to 33c and was rewarming from 33c.The nurse stated that the patient had been shivering so they administered a paralytic recently.The trend shows 1 arrow down.The device was responding appropriately to changes in the patient temperature.Mss encouraged the nurse to continue to treat any heat generation.
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It was reported that the hypothermia patient was rewarming on the arctic sun device.The nurse was confused and had been changing settings.The nurse stated that the patient should have started rewarming at 9:40 am but the arctic sun device already started rewarming around 4:00am.The patient temperature was 33.8c, the water temperature was 23c, flow rate was 2.7l/min and the target temperature was 33c for cooling.Mss explained to nurse that the arctic sun device was set to start rewarming automatically and the 24-hour cooling clock was to start at target.The rewarming showed rewarm from 33.7c at 0.25c/ hour to 36.4c.Mss asked why they were not rewarming to 37c, and nurse changed it.Mss asked for a screen shot.The patient was below the target temperature (31c-32c range) when cooling was started.The rewarming started as little after 4 am and the patient¿s temperature was 34c, so the arctic sun device cooled the patient temperature to 33c.The device was also stopped around 6am.The nurse was not sure who stopped the device.Mss discussed how the device was set up and encouraged the nurse not to change settings randomly.Mss explained that rewarm started after the 24 hours of cooling unless someone decreased the cooling time.The patient was above the 33c cooling target when rewarming started so the device cooled the patient back to 33c and was rewarming from 33c.The nurse stated that the patient had been shivering so they administered a paralytic recently.The trend shows 1 arrow down.The device was responding appropriately to changes in the patient temperature.Mss encouraged the nurse to continue to treat any heat generation.
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The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is incorrect parameters selected.However this cannot be confirmed.The nurse was confused and had been changing settings.The nurse stated that the patient should have started rewarming at 9:40 am but the arctic sun device already started rewarming around 4:00am.The patient temperature was 33.8c, the water temperature was 23c, flow rate was 2.7l/min and the target temperature was 33c for cooling.Mss explained to nurse that the arctic sun device was set to start rewarming automatically and the 24-hour cooling clock was to start at target.The rewarming showed rewarm from 33.7c at 0.25c/ hour to 36.4c.Mss asked why they were not rewarming to 37c, and nurse changed it.Mss asked for a screen shot.The patient was below the target temperature (31c-32c range) when cooling was started.The rewarming started as little after 4 am and the patient¿s temperature was 34c, so the arctic sun device cooled the patient temperature to 33c.The device was also stopped around 6am.The nurse was not sure who stopped the device.Mss discussed how the device was set up and encouraged the nurse not to change settings randomly.Mss explained that rewarm started after the 24 hours of cooling unless someone decreased the cooling time.The patient was above the 33c cooling target when rewarming started so the device cooled the patient back to 33c and was rewarming from 33c.The nurse stated that the patient had been shivering so they administered a paralytic recently.The trend shows 1 arrow down.The device was responding appropriately to changes in the patient temperature.Mss encouraged the nurse to continue to treat any heat generation.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.Potential causes were identified and reviewed.A dhr is not required as review of the shr has determined that this is not an out-of-box failure.The instructions for use were found adequate and state the following: initiate hypothermia (cool patient and rewarm patient) hypothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target temperature from the cool patient and rewarm patient windows in the hypothermia therapy screen.The cool patient window displays the cooling phase patient target temperature and the length of time remaining in the cooling phase of the hypothermia therapy.The rewarm patient window displays the rewarming phase patient target temperature and the length of time remaining in the rewarming phase of the hypothermia therapy.To initiate hypothermia therapy: from the patient therapy selection screen, press the hypothermia button to display the hypothermia therapy screen.1.Cool patient settings ¿ the default patient target temperature and duration will display in the cool patient window.¿ to modify the patient target temperature and duration, press the adjust button to display the cool patient-adjust window.¿ cool patient to: use the up and down arrows on the left side to set the desired patient target temperature to cool the patient ¿ cool patient for: use the up and down arrows on the right side to set the cooling duration to cool the patient before rewarming begins.¿ press the save button to save the new settings and close the cool patient-adjust window 2.Rewarm patient settings ¿ the default patient target temperature and duration will display in the rewarm patient window.¿ to change the rewarming phase patient target temperature and rewarming rate, press the adjust button in the rewarm patient window to display the rewarm patient-adjust screen.Use the up and down arrows on the left side to set the desired final patient target temperature.¿ rewarm patient to: use the up and down arrows on the right side to set the desired final patient target temperature.¿ rewarm at a rate of: use the up and down arrows in the center of the screen to set the rewarming rate.¿ rewarm patient from: when cooling a patient, adjustment of the rewarm patient from setting on the left side of the screen is disabled and defaults to the cool patient target temperature.¿ when rewarming a patient, the rewarm patient from adjustment is enabled and the value can be modified.The rewarm patient from setting is the temperature to which the system is currently controlling the patient.The rewarm patient from temperature will automatically increase as the rewarming process continues.This feature allows the rewarming procedure to be optimized by allowing complete control of the rewarming ramp.Using the rewarm patient from temperature, the rewarm patient to temperature and the rewarming rate settings, the system will calculate and display the rewarming duration and the date/time at which the the patient will reach the final rewarming target temperature.¿ press the save button to save the new settings and close the rewarm patient-adjust window.3.Initiate patient cooling ¿ press start, in the cool patient window to initiate therapy.You will hear a tone and then a voice stating ¿therapy started¿.Additionally, the cool patient window and the arctic sun® temperature management system icon will blink, indicating that therapy is in progress.4.Initiate patient rewarming ¿ upon completion of the cooling phase, there are two options for initiation of patient rewarming, either automatically or manually, depending on the rewarming begins setting in hypothermia settings.¿ if rewarming begins is set to automatically, the rewarming process starts automatically when the cool patient therapy is complete and the duration reaches zero.¿ if rewarming begins is set to manually, the rewarming process starts when the start button is pressed in the rewarm patient window.The cooling process will continue until the rewarm patient start button is pressed.An alert will occur when the cool patient duration reaches zero.End therapy ¿ from the normothermia therapy or hypothermia therapy screen, press the stop button to terminate water circulation to the pads.¿ press the empty pads button, and follow the instructions to purge the pads of water.¿ disconnect the pads from the fluid delivery line.¿ slowly and carefully remove pads from the patient skin.¿ discard the used pads in accordance with hospital procedures for medical waste.¿ press the power switch off." h11: section a through f - 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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