It was reported that a hypothermia patient was rewarming for 2 hours on the arctic sun device.Nurse was confused about when rewarm began and was confused about how the device rewarm works and had been changing the settings.The patient temperature was 33c, water temperature was 27.9c and flow rate was 3.6lpm.The rewarm reads to rewarm from 33.2c to 0.25c/hour to 37c.The device shows 15 hours left to rewarm.Ms and s explained that the device calculates time to rewarm by the rewarm rate and rewarm target.Also explained that if someone changed the rewarm rate the time to rewarm would automatically adjust the hours and count down.The reservoir level showed 5 and they had not added water, but the device appeared to be overfilled.Ms and s walked through draining 500 ml of water from the right drain port.The water temperature rose to 33c quickly.Also explained how the overfill occurred and how the water could not get warm enough.Also recommended the nurse to not keep adjusting the settings.
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The reported issue was confirmed.The root cause of the reported issue was overfill.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "approximately four liters of sterile water will be required to fill the reservoir at initial installation.Fill the reservoir with sterile water only.When filling the control module during initial installation or when completely empty, add one vial of arctic sun¿ temperature management system arctic sun cleaning solution to the sterile water.It is recommended to add the vial when filling with the second liter of sterile water.1) from the patient therapy selection screen, select the button next to either normothermia or hypothermia under the new patient heading.Select any pad type to continue.2) from the hypothermia or normothermia therapy screen, press the fill reservoir button.3) the fill reservoir screen will appear.Follow the directions on the screen.4) the filling process will automatically stop when the reservoir is full.Continue to replace the bottles of sterile water until the filling process stops.5) when the fill reservoir process is complete, the screen will close.6) to stop the process early, press the stop button.Note: if the filling cycle is stopped prior to completion, the reservoir will not be full and may requiring filling after fewer patient therapies have been performed.7) press the cancel button to close the screen." 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.
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It was reported that a hypothermia patient was rewarming for 2 hours on the arctic sun device.Nurse was confused about when rewarm began and was confused about how the device rewarm works and had been changing the settings.The patient temperature was 33c, water temperature was 27.9c and flow rate was 3.6lpm.The rewarm reads to rewarm from 33.2c to 0.25c/hour to 37c.The device shows 15 hours left to rewarm.Ms and s explained that the device calculates time to rewarm by the rewarm rate and rewarm target.Also explained that if someone changed the rewarm rate the time to rewarm would automatically adjust the hours and count down.The reservoir level showed 5 and they had not added water, but the device appeared to be overfilled.Ms and s walked through draining 500 ml of water from the right drain port.The water temperature rose to 33c quickly.Also explained how the overfill occurred and how the water could not get warm enough.Also recommended the nurse to not keep adjusting the settings.
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