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

Model Number 50000000E

Device Problems Insufficient Cooling (1130); Failure to Pump (1502)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

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 cooling device failed when arctic sun device was placed and it showed error 113 ( reduced water temperature control).The device was later pulled out of service and tested by biomedical department who noted error 80 (non-recoverable system error) which meant the control processor failed to detect a simulated water temperature fault.Biomed later contacted the vendor who reported that the mixing pump was not working correctly and was not pushing enough cold water into the lines to cool the patient to the correct temperature and the vendor noted that the pump had to be replaced.The unit was then sent to the vendor for repair.It was also reported by biomed that there was another unit with the same issue and this was also sent for repair.It was further stated that the units had appropriate preventive maintenance.

Event Description

It was reported that the arctic sun device was having issues with the mixing pump and would be coming in for the 2000 hour preventive maintenance service.Per medwatch report received on 04feb2021 it was reported that the device cooling was failed when the arctic sun device was placed it showed an error 113 (reduced water temperature control).The device was later pulled out of the service and tested by the biomedical department noted error 80 (non recoverable system error) which means the control processor failed to detect a simulated water temperature fault.The biomed later contacted the vendor regarding the mixing pump was not working correctly and not pushing the enough cold water into the lines to cool the patient to the correct temperature and the vendor noted that the pump had to be replaced.The unit was sent to the vendor for repair.It was also reported by the biomed that there was another device with the same issue and sent for repair.It was further stated that the units have appropriate preventive maintenance.Per sample evaluation it was reported that the control panel was frozen and unresponsive to touch.The main voltage circuit card electrical terminal and power inlet module showed signs of electrical stress.

Manufacturer Narrative

The reported event was confirmed.The root cause for this failure mode was due to the mixing pump failure.It was further stated that the unit had appropriate preventive maintenance.It was unknown whether the device had met specifications and was influenced by the reported failure.The device was not returned for evaluation.The serial number was unknown therefore the device history record could not be reviewed.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 arctic gel pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.¿ the arctic sun temperature management system is not intended for use in the operating room environment.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 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¿s 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.¿ 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 system¿s 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 arctic gel pads.¿ the arctic gel pads are only for use with the arctic sun® temperature management systems.¿ the arctic gel 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¿s request, either prior to the sterile preparation or sterile draping.Arctic gel 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 arctic gel 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¿s 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 arctic gel pads with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.¿ if accessible, examine the patient¿s skin under the arctic gel pads often, especially those at higher risk of skin injury.Skin injury may occur as a cumulative result of pressure, time and temperature.Possible skin injuries include bruising, tearing, skin ulcerations, blistering, and necrosis.Do not place bean bag or other firm positioning devices under the arctic gel 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 arctic gel 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 arctic gel pads over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ if needed, place defibrillation pads between the arctic gel pads and the patient¿s skin.¿ carefully remove arctic gel pads from the patient¿s skin at the completion of use.Discard used arctic gel 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 device was not returned.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11386907
• MDR Text Key: 242048632
• Report Number: 1018233-2021-00842
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other