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It was reported that (b)(6) hypothermia patient cooling on the arctic sun device (serial (b)(4)) for several hours.Nurse reported that the device lost power and seemed to have trouble loading the software.The screen was yellow.They were not the nurse who did the troubleshooting, so information was limited.Nurse restarted the device and started the treatment over instead of resuming current patient.Nurse wanted to make sure the settings were correct.Rectal probe was in place.Target temperature was 36c, patient temperature was 37c, water temperature was 8.2c and flow rate was 2.2lpm.Four small arctic gel pads were in place.Patient weighed (b)(6) kilograms.Nurse stated the pads provided good coverage.Event log showed one alarm 45 (ac power lost low priority alarm- the ac power was lost while the power switch was in the ¿on¿ position).Mss explained this alarm.The nurse stated the device might have been plugged into the bed.Currently the device was plugged into a wall outlet.Mss explained that plugging the device into a bed could lead to power loss.The cool patient was set to cool for 69 hours.Mss explained that it appeared the device was programmed for a neonate, thus the 69 hours of cooling was left and patient cooling for 3 hours.Mss recommended the nurse to speak to the patient's doctor regarding cooling time.Nurse stated that for older children they use the adult protocol and adjusted the cooling time to 24 hours.Nurse would also verify with the doctor.Mss discussed causes of heat generation.The nurse stated the patient had been shivering for some time.They recently increased sedation and shivering had stopped.The device had a good flow rate and water was cold.The device had a good flow rate and water was cold.Mss advised to be diligent with skin checks.The device was working as programmed.Mss also recommended the nurse change out the device if the power loss reoccurred.During the second call from facility, nurse called to let them know that the arctic sun device (serial (b)(4)) stopped again.The nurse reported that the device displayed something about load program not responding, close program.Nurse closed the program, and the device displayed a yellow screen and device displayed a message about communication disabled or disconnected.Nurse cycled the power, and the device was beeping intermittently.Rectal probe was in place and the patient temperature was confirmed with another source.Event log only showed one alarm 45 (ac power lost low priority alarm- the ac power was lost while the power switch was in the ¿on¿ position).Mss recommended the nurse to change out the device and send this one to the biomedical engineering department for evaluation.Mss walked the nurse through switching to another arctic sun device (serial (b)(4)) and adjusting cooling time to 15 hours.Low water temperature limit was 8c, patient temperature was 37.2c, target temperature was 36c, flow rate was 2.3lpm and water temperature was 12c.Mss discussed heat generation again and explained the work to cool function.Electroencephalogram (eeg) showed no seizure activity.Mss discussed the importance of heat generation management as the water was cold.The nurse reported that the patient had been cooling since 2pm yesterday.Mss advised to be diligent with skin checks.There were no obvious signs of shivering.The nurse stated that the patient was sedated.Nurse would speak to the doctor about management of the heat generation and counter warming.
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The reported issue was inconclusive.The device was not returned.The root cause of the reported issue could not be determined.A potential root cause was incorrect outlet used.However this cannot be confirmed.It was unknown if the device met specifications and whether the device was influenced by the reported failure.The device was in use 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: "the arctic sun® temperature management system is intended for monitoring and controlling patient temperature.Warnings and cautions warnings ¿ do not use the arctic sun® temperature management system in the presence of flammable agents because an explosion and/or fire may result.¿ do not use high frequency surgical instruments or endocardial catheters while the arctic sun® temperature management system is in use.¿ there is a risk of electrical shock and hazardous moving parts.There are no user serviceable parts inside.Do not remove covers.Refer servicing to qualified personnel.¿ power cord has a hospital grade plug.Grounding reliability can only be achieved when connected to an equivalent receptacle marked ¿hospital use¿ or ¿hospital grade¿.¿ when using the arctic sun® temperature management system, note that all other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the arctic sun® temperature management system may actually alter or interfere with patient temperature control.¿ do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.Cautions ¿ this product is to be used by or under the supervision of trained, qualified medical personnel.¿ federal law (usa) restricts this device to sale, by or on the order of a physician.¿ use only distilled or sterile water.The use of other fluids will damage the arctic sun® temperature management system system.¿ when moving the arctic sun® temperature management system always use the handle to lift the controller over an obstacle to avoid over balancing.¿ the patient bed surface should be located between 30 and 60 inches (75 cm and 150 cm) above the floor to ensure proper flow and minimize risk of leaks.¿ the clinician is responsible to determine the appropriateness of custom parameters.When the system is powered off, all changes to parameters will revert to the default unless the new settings have been saved as new defaults in the advanced setup screen.For small patients (=30 kg) it is recommended to use the following settings: water temperature high limit =40°c (104°f); water temperature low limit =10°c (50 °f); control strategy =2.¿ the operator must continuously monitor patient temperature when using manual control and adjust the temperature of the water flowing through the pads accordingly.Patient temperature will not be controlled by the arctic sun® temperature management system in manual control.¿ due to the systems high efficiency, manual control is not recommended for long duration use.The operator is advised to use the automatic therapy modes (e.G.Control patient, cool patient, rewarm patient) for automatic patient temperature monitoring and control.¿ the arctic sun® temperature management system will monitor and control patient core temperature based on the temperature probe attached to the system.The clinician is responsible for correctly placing the temperature probe and verifying the accuracy and placement of the patient probe at the start of the procedure.¿ medivance recommends measuring patient temperature from a second site to verify patient temperature.Medivance recommends the use of a second patient temperature probe connected to the arctic sun® temperature management system temperature 2 input as it provides continuous monitoring and safety alarm features.Alternatively, patient temperature may be verified periodically with independent instrumentation.¿ the displayed temperature graph is for general information purposes only and is not intended to replace standard medical record documentation for use in therapy decisions.¿ patient temperature will not be controlled and alarms are not enabled in stop mode.Patient temperature may increase or decrease with the arctic sun® temperature management system in stop mode.¿ carefully observe the system for air leaks before and during use.If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections.If needed, replace the leaking pad.Leakage may result in lower flow rates and potentially decrease the performance of the system.¿ the arctic sun® temperature management system is for use only with the arcticgel¿ pads.¿ the arcticgel¿ pads are only for use with the arctic sun® temperature management systems.¿ the arcticgel¿ pads are non-sterile for single patient use.Do not reprocess or sterilize.If used in a sterile environment, pads should be placed according to the physician request, either prior to the sterile preparation or sterile draping.Arcticgel¿ pads should not be placed on a sterile field.¿ use pads immediately after opening.Do not store pads once the kit has been opened.¿ do not place arcticgel¿ pads on skin that has signs of ulceration, burns, hives, or rash.¿ while there are no known allergies to hydrogel materials, caution should be exercised with any patient who has a history of skin allergies or sensitivities.¿ do not allow circulating water to contaminate the sterile field when patient lines are disconnected.¿ the water content of the hydrogel affects the pad adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature.Periodically check that pads remain moist and adherent.Replace pads when the hydrogel no longer uniformly adheres to the skin.Replacing pads at least every 5 days is recommended.¿ do not puncture the arcticgel¿ pads with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.¿ if accessible, examine the patient skin under the arcticgel¿ pads often, especially those at higher risk of skin injury.Skin injury may occur as a cumulative result of pressure, time and temperature.Do not place bean bag or other firm positioning devices under the arcticgel¿ pads.Do not place positioning devices under the pad manifolds or patient lines.¿ the rate of temperature change and potentially the final achievable patient temperature is affected by many factors.Treatment application, monitoring and results are the responsibility of the attending physician.If the patient does not reach target temperature in a reasonable time or the patient is not able to be maintained at the target temperature, the skin may be exposed to low or high water temperatures for an extended period of time which may increase the risk for skin injury.Ensure that pad sizing / coverage and custom parameter settings are correct for the patient and treatment goals, water flow is greater than or equal to 2.3 liters per minute and the patient temperature probe is in the correct place.For patient cooling, ensure environmental factors such as excessively hot rooms, heat lamps, and heated nebulizers are eliminated and patient shivering is controlled.Otherwise, consider increasing minimum water temperature, modifying target temperature to an attainable setting or discontinuing treatment.For patient warming, consider decreasing maximum water temperature, modifying target temperature to an attainable setting or discontinuing treatment.¿ due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold.Patients at risk include those with poor tissue perfusion or poor skin integrity due to diabetes, peripheral vascular disease, poor nutritional status, steroid use or high dose vasopressor therapy.If warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.¿ do not allow urine, antibacterial solutions or other agents to pool underneath the arcticgel¿ pads.Urine and antibacterial agents can absorb into the pad hydrogel and cause chemical injury and loss of pad adhesion.Replace pads immediately if these fluids come into contact with the hydrogel.¿ do not place arcticgel¿ pads over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ if needed, place defibrillation pads between the arcticgel¿ pads and the patient¿s skin.¿ carefully remove arcticgel¿ pads from the patient¿s skin at the completion of use.Discard used arcticgel¿ pads in accordance with hospital procedures for medical waste.¿ the usb data port is to be used only with a standalone usb flash drive.Do not connect to another mains powered device during patient treatment.¿ users should not use cleaning or decontamination methods different from those recommended by the manufacturer without first checking with the manufacturer that the proposed methods will not damage the equipment.Do not use bleach (sodium hypochlorite) as it may damage the system.¿ medivance will not be responsible for patient safety or equipment performance if the procedures to operate, maintain, modify or service the medivance arctic sun® temperature management system are other than those specified by medivance.Anyone performing the procedures must be appropriately trained and qualified." correction: g 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.H3 other text : the device was not returned.
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It was reported that sixteen-year-old hypothermia patient cooling on the arctic sun device (serial (b)(6)) for several hours.Nurse reported that the device lost power and seemed to have trouble loading the software.The screen was yellow.They were not the nurse who did the troubleshooting, so information was limited.Nurse restarted the device and started the treatment over instead of resuming current patient.Nurse wanted to make sure the settings were correct.Rectal probe was in place.Target temperature was 36c, patient temperature was 37c, water temperature was 8.2c and flow rate was 2.2lpm.Four small arctic gel pads were in place.Patient weighed 60 kilograms.Nurse stated the pads provided good coverage.Event log showed one alarm 45 (ac power lost low priority alarm- the ac power was lost while the power switch was in the ¿on¿ position).Mss explained this alarm.The nurse stated the device might have been plugged into the bed.Currently the device was plugged into a wall outlet.Mss explained that plugging the device into a bed could lead to power loss.The cool patient was set to cool for 69 hours.Mss explained that it appeared the device was programmed for a neonate, thus the 69 hours of cooling was left and patient cooling for 3 hours.Mss recommended the nurse to speak to the patient's doctor regarding cooling time.Nurse stated that for older children they use the adult protocol and adjusted the cooling time to 24 hours.Nurse would also verify with the doctor.Mss discussed causes of heat generation.The nurse stated the patient had been shivering for some time.They recently increased sedation and shivering had stopped.The device had a good flow rate and water was cold.The device had a good flow rate and water was cold.Mss advised to be diligent with skin checks.The device was working as programmed.Mss also recommended the nurse change out the device if the power loss reoccurred.During the second call from facility, nurse called to let them know that the arctic sun device (serial (b)(6)) stopped again.The nurse reported that the device displayed something about load program not responding, close program.Nurse closed the program, and the device displayed a yellow screen and device displayed a message about communication disabled or disconnected.Nurse cycled the power, and the device was beeping intermittently.Rectal probe was in place and the patient temperature was confirmed with another source.Event log only showed one alarm 45 (ac power lost low priority alarm- the ac power was lost while the power switch was in the ¿on¿ position).Mss recommended the nurse to change out the device and send this one to the biomedical engineering department for evaluation.Mss walked the nurse through switching to another arctic sun device (serial (b)(6)) and adjusting cooling time to 15 hours.Low water temperature limit was 8c, patient temperature was 37.2c, target temperature was 36c, flow rate was 2.3lpm and water temperature was 12c.Mss discussed heat generation again and explained the work to cool function.Electroencephalogram (eeg) showed no seizure activity.Mss discussed the importance of heat generation management as the water was cold.The nurse reported that the patient had been cooling since 2pm yesterday.Mss advised to be diligent with skin checks.There were no obvious signs of shivering.The nurse stated that the patient was sedated.Nurse would speak to the doctor about management of the heat generation and counter warming.
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