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

Model Number 50000000

Device Problems Insufficient Heating (1287); Moisture Damage (1405); Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.

Event Description

It was reported that the device was giving an alarm 115 (prolonged warm water exposure).The water temperature was 42.1c, the patient's temperature was 34.5c with a target temperature of 37c, and the flow rate was optimal at 2.4 l/min.The complainant advised that the patient was 111kg with four large pads in place.It was recommended to add a universal pad to cover the abdomen.The complainant also noted the patient was alert and able to follow commands, however was now sedated with both bolus and continuous medications.Per troubleshooting, the rewarm tab read from 35.7c at a rate of 0.25c per hour to 37c.It was suggested to add a bair hugger and cover the head, hands, and feet and to turn on the vent warmer.The complainant was also advised to perform diligent skin checks.Two hours later, a universal pad was added and the patient was covered.The patient's temperature was noted at 36.5c, the water temperature was 25.1c, and the flow rate was optimal at 2.3 l/min.The rewarm tab read 36.1c at 0.25c per hour to 37c.A second call was received several hours later and the complainant noted that the patient was now being maintained at the target temperature of 37c; however, the device alarmed and shutting off at intervals.The patient's temperature was 35.9c, the water temperature was 42.1c, and the flow rate was optimal at 2.3 l/min.Per the event log, an alarm 115 was noted multiple times.The complainant was advised that the device was responding appropriately to bring the patient's temperature back up to target.Per follow up, therapy was continued with no further issues.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be the patient's clinical condition as medication was given to combat shivering.However, this cannot be confirmed.Per troubleshooting, the rewarm tab read from 35.7c at a rate of 0.25c per hour to 37c.It was suggested to add a bair hugger and cover the head, hands, and feet and to turn on the vent warmer.The complainant was also advised to perform diligent skin checks.The complainant was advised that the device was responding appropriately to bring the patient's temperature back up to target.Per follow up, therapy was continuing with no further issues.The device was operating properly and remained in service.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "the arctic sun® temperature management system is a thermal regulating system, indicated 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 supplies temperature simulators (fixed value resistors) for testing, training and demonstration purposes.Never use this device, or other method, to circumvent the normal patient temperature feedback control when the system is connected to the patient.Doing so exposes the patient to the hazards associated with severe hypo- or hyper-thermia.¿ 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.The arctic sun® temperature management system is not intended for use in the operating room environment.".

Event Description

It was reported that the device was giving an alarm 115 (prolonged warm water exposure).The water temperature was 42.1c, the patient's temperature was 34.5c with a target temperature of 37c, and the flow rate was optimal at 2.4 l/min.The complainant advised that the patient was 111kg with four large pads in place.It was recommended to add a universal pad to cover the abdomen.The complainant also noted the patient was alert and able to follow commands, however was now sedated with both bolus and continuous medications.Per troubleshooting, the rewarm tab read from 35.7c at a rate of 0.25c per hour to 37c.It was suggested to add a bair hugger and cover the head, hands, and feet and to turn on the vent warmer.The complainant was also advised to perform diligent skin checks.Two hours later, a universal pad was added and the patient was covered.The patient's temperature was noted at 36.5c, the water temperature was 25.1c, and the flow rate was optimal at 2.3 l/min.The rewarm tab read 36.1c at 0.25c per hour to 37c.A second call was received several hours later and the complainant noted that the patient was now being maintained at the target temperature of 37c; however, the device alarmed and shutting off at intervals.The patient's temperature was 35.9c, the water temperature was 42.1c, and the flow rate was optimal at 2.3 l/min.Per the event log, an alarm 115 was noted multiple times.The complainant was advised that the device was responding appropriately to bring the patient's temperature back up to target.Per follow up, therapy was continued with no further issues.

• 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: 7373496
• MDR Text Key: 103584287
• Report Number: 1018233-2018-00960
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 04/25/2018
• Supplement Dates FDA Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 111