It was reported that the patient was not heating on the arctic sun device.The patient was in cooling mode, but the pads felt warm and water temperature was at 40c.There was also a low flow alert (alert 02).Patient temperature was 33.7c and target was 36c.Ms&s explained that the device was trying to warm the patient up to target, and the pads should not feel cold if the patient was below target.Flow rate was 0.8lpm because the patient only had a universal pad on the their back because they did not have a small set of pads.Ms&s explained that a universal pad alone was not going to do anything.They had a large set of pads and ms&s advised that they could overlap as much as they needed to and use a full set rather than a single universal pad.Per follow up via phone on (b)(6) 2020 the nurse stated they changed the pads and that seemed to solve the issue.The patient was still completing therapy on the device with no further issues.
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It was reported that the patient was not heating on the arctic sun device.The patient was in cooling mode, but the pads felt warm and water temperature was at 40c.There was also a low flow alert (alert 02).Patient temperature was 33.7c and target was 36c.Ms&s explained that the device was trying to warm the patient up to target, and the pads should not feel cold if the patient was below target.Flow rate was 0.8lpm because the patient only had a universal pad on the their back because they did not have a small set of pads.Ms&s explained that a universal pad alone was not going to do anything.They had a large set of pads and ms&s advised that they could overlap as much as they needed to and use a full set rather than a single universal pad.Per follow up via phone on 30jan2020 the nurse stated they changed the pads and that seemed to solve the issue.The patient was still completing therapy on the device with no further issues.
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The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿incorrect water flow¿.A potential root cause for this failure could be " inadequate channel design".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: "directions for use 1.Arcticgel¿ pads are only for use with an arctic sun® temperature management system control module.See operators manual for detailed instructions on system use.2.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the maximum number and largest size pads.3.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.4.Place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion.5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.7.When finished, empty water from pads.Cold temperature increases the adhesiveness of the hydrogel.For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm.Slowly remove pads from the patient and discard.".
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