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| Model Number 50000000 |
| Device Problem
Fracture (1260)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/08/2022 |
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Event Type
malfunction
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Event Description
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It was reported that the arctic sun device was alerting air leak and no flow.They changed to a second device (serial (b)(4)) and with new set of arctic gel pads.During therapy on the first device (serial (b)(4)) all lines were straight with no bends or kinks, 4 arctic gel pads were connected, fluid delivery line (fdl) was secure and intact, and device had good airflow to back.Nurse was alerting low air leak and no flow.Nurse changed to a new set of pads.Other pads were new as well.System diagnostics showed that outlet monitor temperature (t1) was 11.3c, outlet control temperature (t2) was 11.2c, inlet temperature (t3) was 22.6c, chiller temperature (t4) was 4.1c, water flow rate was 0lpm, inlet pressure was -1.2 psi, circulation pump command was 100 percent, mixing pump command was 100 percent, heater command was 0 percent, water reservoir level was 4 bars, system hours were 10365.1 and pump hours were 9725.3.During therapy on the second device (serial (b)(4)) all lines were straight with no bends or kinks, 4 arctic gel pads connected, fluid delivery line (fdl) was secure and intact, and device had good airflow to back.The device was alerting low air leak and no flow (serial (b)(4)) with the new set of pads.Both sets of new pads gave same alerts on this device as well.In manual control at 30c system diagnostics showed that outlet monitor temperature (t1) was 17.4c, outlet control temperature (t2) was 17.2c, inlet temperature (t3) was 17c, chiller temperature (t4) was 5.5c, water flow rate was 1.6lpm, inlet pressure was -1.1psi, circulation pump command was 100 percent, mixing pump command was 100 percent, heater command was 0 percent, water reservoir level was 3 bars, system hours were 11158.8 and pump hours were 10630.4.The 3rd device was hooked up to same new pads.The device primed and leveled out with flow rate was 3.4lpm.Flow rate was maintained for a couple of minutes before disconnecting with caller.Mss advised to send 1st two devices to biomed and call with any questions.Per follow up information received on 22sep2022, nurse stated there were no patient injuries and patient was able to continue therapy on different device.Per sample evaluation results received on 08nov2022 for the first device with serial# (b)(4), it was reported that the neutral side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Tank seals were frayed.During pump servicing both circulation pump motor and mixing pump motor had cracked thread housings that hold the pump bolts in place.The double bend tube and the chiller evaporator outlet tube were found expanded during servicing.Tank seals were found lifted from the tank.The chiller pump molded tube was replaced due to the old one tearing while removing the tank for seal replacement.Per sample evaluation results received on 08nov2022 for the second device with serial# (b)(4), replacement of double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.Replacement of the tank seals due to lifting from the tank.Replaced the outer shell due to a sheared off retaining bolt and the power cord due to frayed end.The root cause of the reported issue was due to a weak circulation pump.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the arctic sun device was alerting air leak and no flow.They changed to a second device (serial (b)(6)) and with new set of arctic gel pads.During therapy on the first device (serial (b)(6) ) all lines were straight with no bends or kinks, 4 arctic gel pads were connected, fluid delivery line (fdl) was secure and intact, and device had good airflow to back.Nurse was alerting low air leak and no flow.Nurse changed to a new set of pads.Other pads were new as well.System diagnostics showed that outlet monitor temperature (t1) was 11.3c, outlet control temperature (t2) was 11.2c, inlet temperature (t3) was 22.6c, chiller temperature (t4) was 4.1c, water flow rate was 0lpm, inlet pressure was -1.2 psi, circulation pump command was 100 percent, mixing pump command was 100 percent, heater command was 0 percent, water reservoir level was 4 bars, system hours were 10365.1 and pump hours were 9725.3.During therapy on the second device (serial (b)(6)) all lines were straight with no bends or kinks, 4 arctic gel pads connected, fluid delivery line (fdl) was secure and intact, and device had good airflow to back.The device was alerting low air leak and no flow (serial (b)(6)) with the new set of pads.Both sets of new pads gave same alerts on this device as well.In manual control at 30c system diagnostics showed that outlet monitor temperature (t1) was 17.4c, outlet control temperature (t2) was 17.2c, inlet temperature (t3) was 17c, chiller temperature (t4) was 5.5c, water flow rate was 1.6lpm, inlet pressure was -1.1psi, circulation pump command was 100 percent, mixing pump command was 100 percent, heater command was 0 percent, water reservoir level was 3 bars, system hours were 11158.8 and pump hours were 10630.4.The 3rd device was hooked up to same new pads.The device primed and leveled out with flow rate was 3.4lpm.Flow rate was maintained for a couple of minutes before disconnecting with caller.Mss advised to send 1st two devices to biomed and call with any questions.Per follow up information received on 22sep2022, nurse stated there were no patient injuries and patient was able to continue therapy on different device.Per sample evaluation results received on 08nov2022 for the first device with serial# (b)(6), it was reported that the neutral side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Tank seals were frayed.During pump servicing both circulation pump motor and mixing pump motor had cracked thread housings that hold the pump bolts in place.The double bend tube and the chiller evaporator outlet tube were found expanded during servicing.Tank seals were found lifted from the tank.The chiller pump molded tube was replaced due to the old one tearing while removing the tank for seal replacement.Per sample evaluation results received on 08nov2022 for the second device with serial# (b)(6), replacement of double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.Replacement of the tank seals due to lifting from the tank.Replaced the outer shell due to a sheared off retaining bolt and the power cord due to frayed end.The root cause of the reported issue was due to a weak circulation pump.
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Manufacturer Narrative
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The reported issue was confirmed.The reported issue was confirmed, however the root cause was not able to be isolated.A potential root cause could be due to stress- or impact-induced fracturing or weakening of internal components.The device was evaluated and the reported issue was confirmed as it was noted that the circulation pump motor had cracked thread housings that hold the pump bolts in place.Replaced circulation pump motor.Completed the 2000-hour pm procedure on the device.Serviced the circulation pump and mixing pump replaced heater lot 1422 with lot 2151, and replaced both manifold o-rings and drain valves.He device was put through a functional check.The device was heated to 42°c and cooled to 4°c and was stable at 28°c with a flow of 1.8 l/m with -7.0 psi in bypass mode.The device was placed on acats (automated calibration and test system).An electrical safety test was performed.A final inspection was performed.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.Based on the results of the investigation, no additional actions are needed.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.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.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.It is recommended to use the patient temperature high and patient temperature low alert settings.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 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¿s 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¿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 arcticgel¿ 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 arcticgel¿ 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 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 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.
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