MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE

Model Number 50000000E

Device Problems Display or Visual Feedback Problem (1184); Insufficient Heating (1287); Temperature Problem (3022)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient was not rewarming on the arctic sun device.The nurse thought might be an additional water was needed.The patient temperature was 34.6c and rewarmed from 37c at 0.3c/hr to 37c.The flow rate was 2.6lpm.The arctic sun device had an alert 03 (water reservoir low) and an alarm 15 (unable to obtain a stable patient temperature) present in event log from last night.The water level was 3 the pump hours were 1073.1, the system hours were 1134.8 and the heater command 100%.The nurse had emptied the arctic gel pads and the water level was full.The nurse did not thought that the water was added last night when they received an alert 03 (water reservoir low).Drained 400ml from circulation tank.The water temperature was increasing to mid 30cs before making adjustments.Rewarm from adjusted to current patient temperature at 34.7c.Called back an hour later.The patient's nurse was in the background and stated that nurse had placed the arctic sun device in manual mode to 94f.Currently patient temperature was 34.7c.Rewarmed from 35.3c and the water temperature was 28.3c.The user decided to change the arctic sun device.Asked nurse to have biomed check heater.Described how to set up new arctic sun device and reminded the user to empty the arctic gel pads first.Per follow up via nurse on (b)(6) 2020, they switched out devices and added a universal pad to complete therapy.The first device was sent to biomed.

Manufacturer Narrative

The reported event was unconfirmed, as the problem could not be reproduced.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be due to outlet water temperature regulation error but which was still within the allowable water temperature range.However, this could not be confirmed.The device had met specifications and was not 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: "the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.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.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 (64.4 °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." 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 evaluated by the facility's biomed.

Event Description

It was reported that the patient was not rewarming on the arctic sun device.The nurse thought might be an additional water was needed.The patient temperature was 34.6c and rewarmed from 37c at 0.3c/hr to 37c.The flow rate was 2.6 lpm.The arctic sun device had an alert 03 (water reservoir low) and an alarm 15 (unable to obtain a stable patient temperature) present in event log from the last night.The water level was 3 the pump hours were 1073.1, the system hours were 1134.8 and the heater command was 100%.The nurse had emptied the arctic gel pads and the water level was full.The nurse did not thought that the water was added last night when they received an alert 03 (water reservoir low).The nurse drained 400ml from the circulation tank.The water temperature was increased to mid 30cs before making the adjustments.The rewarm adjusted to the current patient temperature at 34.7c.The patient's nurse was in the background and stated that the nurse had placed the arctic sun device in manual mode to 94f.Currently the patient temperature was 34.7c.Rewarmed from 35.3c and the water temperature was 28.3c.The user decided to change the arctic sun device.Ms and s asked the nurse to check the heater with the biomed.Ms and s described how to set up the new arctic sun device and reminded the user to empty the arctic gel pads first.Per follow up via nurse on 11sep2020, they switched out the devices and added a universal pad to complete the therapy.The first device was sent to biomed.Per follow up via biomed on 14oct2020, it was stated that the biomed did a full calibration on device and returned the device to service.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10614205
• MDR Text Key: 214568054
• Report Number: 1018233-2020-06283
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1