It reported that the patient was above the target temperature on the artic sun device.The patient's temperature was 37c, the water temperature was 7.8c and the flow rate was 0.7lpm.The patient was 36kg and had one universal pad on her torso.Ms&s explained that due to lack of adequate coverage, the water temperature would be very cold.The nurse was able to locate a set of extra small pads in the supply room.The patient was sedated.Not paralyzed, had no visible shivering but possible micro shivering.Per follow up, the nurse changed the universal pad to a small set.The patent was able to complete therapy and reach the target temperature.
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It reported that the patient was above the target temperature on the artic sun device.The patient's temperature was 37c, the water temperature was 7.8c and the flow rate was 0.7lpm.The patient was 36kg and had one universal pad on her torso.Ms&s explained that due to lack of adequate coverage, the water temperature would be very cold.The nurse was able to locate a set of extra small pads in the supply room.The patient was sedated.Not paralyzed, had no visible shivering but possible micro shivering.Per follow up, the nurse changed the universal pad to a small set.The patent was able to complete therapy and reach the target temperature.
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The reported event was confirmed to be use-related.No sample was returned for evaluation.It is therefore unknown if the device failed to meet specification.The device was being used for treatment at the time of the reported event.The failure mode was '1.1 incorrect product selection effect i: prolongation of therapy¿ with a root cause of '1.1.2 incorrect size selected.¿ 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 entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.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 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).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." corrections: concomitant medical products , device evaluated by mfr.
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