The reported issue was confirmed.The root cause of the reported issue was confirmed to be overfilling causing insufficient heating.The device did not meet specifications, and was influenced by the reported failure.The device was used on a patient.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: "fu for filling reservoir: fill reservoir 1) fill the reservoir with sterile water only.2) four liters of water will be required to fill the reservoir at initial installation.3) add one vial of arctic sun® temperature management system cleaning solution to the sterile water.4) from the patient therapy selection screen, press either the normothermia or hypothermia button, under the new patient heading.5) from the hypothermia or normothermia therapy screen, press the fill reservoir button.6) the fill reservoir screen will appear.Follow the directions on the screen." h11:section a through f - 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.H3 other text : the device was not returned.
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It was reported that the patient was in rewarming phase.They were rewarming for over 2 hrs according to nurse and water temperature was not increasing much.The nurse switched out arctic sun device before calling and nurse called to see if mss knew why that might have happened.Mss explained there could be several reasons including the heater being out.Per follow-up received on (b)(6) 2021, nurse was unaware of issue.Per follow-up received on (b)(6) 2021, sn (b)(6) received for not heating.Device overfilled.Once water drained, there was no further issues.Device back in service.
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