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| Catalog Number 50000000E |
| Device Problem
Inaccurate Flow Rate (1249)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/22/2024 |
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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 alerting low flow.They had tried emptying and disconnecting and reconnecting but no resolution.Patient had been on treatment for some time.Issues arose around 16:00, patient temperature (pt) was 27.6c via esophageal probe.Axillary reading 34.3c, targeted temperature (tt) was 33.5c, water temperature (wt) was 7c, water flow rate (wfr) was 0 l/m.Neonatal pad in place, had them check probe connections and esophageal now reading 34.8c.Tried stopping therapy, draining pads and device alerted, empty pads not complete.Tried again with same alert.Emptied pads over trash can.Walked through proper disconnect and reconnect.All lines straight with no bends or kinks.Restarted therapy and device alerted low flow with 0 l/m.System diagnostics were outlet monitor temperature (t1) was 6.5c, outlet control temperature (t2) was 6.6c, inlet temperature (t3) was 22.4c, chiller temperature (t4) was 4.3c, water flow rate (wfr) was 0, inlet pressure (ip) was -7.1, circulation pump command (cpc) was 19 percentage, mixing pump command (mpc) was 18 percentage, heater command (hc) was 0, water reservoir level (wrl) was 4, system hours were 1247.3, pump hours were 1185.3.Had them stop therapy, drain, and disconnect pads.Placed device in manual control at 30c.System diagnostics with no pads, outlet monitor temperature (t1) was 10.9c, outlet control temperature (t2) was 10.7c, inlet temperature (t3) was 11.1c, chiller temperature (t4) was 10.2c, water flow rate (wfr) was 0.9 l/m, inlet pressure (ip) was -6.9psi, circulation pump command (cpc) was 33 percentage, mixing pump command (mpc) was 0, heater command (hc) was 100 percentage.Walked through disabling manual control and advised to swap out pads.Set these pads aside for follow up from tm/cm.Encouraged to call back with any questions or concerns.2nd call received 23feb2023, swapped out pads last night and device was working fine, but now it has been alerting low flow again and water flow rate (wfr) was 0 l/m.Patient temperature (pt) was 33.8c, targeted temperature (tt) was 33.5c 11 hours remaining to cool patient.System diagnostics chiller temperature (t4) was 18.5c, water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -3.7psi, circulation pump command (cpc) was 0, mixing pump command (mpc) was 0, heater command (hc) was 0.Had them stop therapy and empty pads.Device alerted empty pads not complete.Disconnected over trash can.Placed in manual control at 25c with no pads, system diagnostics, chiller temperature (t4) was 6.7c, water flow rate (wfr) was 1.1 l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 37 percentage, mixing pump command (mpc) was 0, heater command (hc) was 100 percentage.Had them stop therapy and disable manual control.Advised to swap out devices and send to biomed labeled low flow.Circulation pump command (cpc) and water flow rate (wfr) values were not sufficient for manual control with no pads and device needs to be evaluated.
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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.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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Manufacturer Narrative
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The reported issue was inconclusive.The device was not returned.The root cause of the reported issue could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be a failed pressure transducer.However, there was insufficient information to confirm this potential root cause.A dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The instructions for use were found adequate and state the following: ¿indications for use the arctic sun® temperature management system is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.Warnings and cautions warnings ¿ do not use the arctic sun® temperature management system in the presence of flammable agents because of 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." 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.
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Event Description
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It was reported that the arctic sun device alerting low flow.They had tried emptying and disconnecting and reconnecting but no resolution.Patient had been on treatment for some time.Issues arose around 16:00, patient temperature (pt) was 27.6c via esophageal probe.Axillary reading 34.3c, targeted temperature (tt) was 33.5c, water temperature (wt) was 7c, water flow rate (wfr) was 0 l/m.Neonatal pad in place, had them check probe connections and esophageal now reading 34.8c.Tried stopping therapy, draining pads and device alerted, empty pads not complete.Tried again with same alert.Emptied pads over trash can.Walked through proper disconnect and reconnect.All lines straight with no bends or kinks.Restarted therapy and device alerted low flow with 0 l/m.System diagnostics were outlet monitor temperature (t1) was 6.5c, outlet control temperature (t2) was 6.6c, inlet temperature (t3) was 22.4c, chiller temperature (t4) was 4.3c, water flow rate (wfr) was 0, inlet pressure (ip) was -7.1, circulation pump command (cpc) was 19%, mixing pump command (mpc) was 18%, heater command (hc) was 0, water reservoir level (wrl) was 4, system hours were 1247.3, pump hours were 1185.3.Had them stop therapy, drain, and disconnect pads.Placed device in manual control at 30c.System diagnostics with no pads, outlet monitor temperature (t1) was 10.9c, outlet control temperature (t2) was 10.7c, inlet temperature (t3) was 11.1c, chiller temperature (t4) was 10.2c, water flow rate (wfr) was 0.9 l/m, inlet pressure (ip) was -6.9psi, circulation pump command (cpc) was 33%, mixing pump command (mpc) was 0, heater command (hc) was 100%.Walked through disabling manual control and advised to swap out pads.Set these pads aside for follow up from tm/cm.Encouraged to call back with any questions or concerns.2nd call received 23feb2023, swapped out pads last night and device was working fine, but now it has been alerting low flow again and water flow rate (wfr) was 0 l/m.Patient temperature (pt) was 33.8c, targeted temperature (tt) was 33.5c 11 hours remaining to cool patient.System diagnostics chiller temperature (t4) was 18.5c, water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -3.7psi, circulation pump command (cpc) was 0, mixing pump command (mpc) was 0, heater command (hc) was 0.Had them stop therapy and empty pads.Device alerted empty pads not complete.Disconnected over trash can.Placed in manual control at 25c with no pads, system diagnostics, chiller temperature (t4) was 6.7c, water flow rate (wfr) was 1.1 l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 37%, mixing pump command (mpc) was 0, heater command (hc) was 100%.Had them stop therapy and disable manual control.Advised to swap out devices and send to biomed labeled low flow.Circulation pump command (cpc) and water flow rate (wfr) values were not sufficient for manual control with no pads and device needs to be evaluated.Per follow up information received via phone on 19mar2024, it was reported that the therapy was completed on the male baby that was less than 24 hours old and weighed less than 10 pounds without any impact.They were advised by mis to empty the pads and refill them.The pads were then replaced, that resolved the issue.The malfunctioning pads were discarded.The nurse was not sure if the device was sent to biomed.
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Search Alerts/Recalls
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