MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; ARCTIC GEL PAD
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Catalog Number 318-02 |
Device Problems
Inaccurate Flow Rate (1249); Insufficient Heating (1287); Insufficient Flow or Under Infusion (2182); Device Sensing Problem (2917)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2020 |
Event Type
malfunction
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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 neonatal arctic gel pad flow rate was 0.2 lpm and the water temperature would not increase and the patient's temperature dropped to 31.85 °c.The arctic gel pad was replaced due to low flow and after some time, error 74 (non-recoverable system error secondary outlet water temperature sensor out of range ¿ low resistances) appeared for 4 times.The arctic sun device switched to the substitute.In case that the connector to set an arctic gel pad to the main body rotated 180 degrees, it operated correctly so that the water flow was 1.1 lpm.The representative visited the hospital on the day and confirmed that the newborn cooling pad was connected to the arctic sun device and started using it.After using it, the flow rate of the arctic gel pad was only 0.2lpm, but since the body temperature decreasing towards the target temperature and the arctic gel pad was expensive, the user continued to use it.After some time, the body temperature reached 33.5c, but the flow rate was 0.2lpm, the heater control was applied and the water temperature would not warm and the body temperature continued to drop to 31.5c.After that, the water temperature was balanced with the body temperature, so the heater would not turn on but the body temperature would not drop any further.The user exchanged the arctic gel pad and the flow rate was 1.0 lpm and the normal operation was achieved.The combination of the container and the arctic gel pad was confirmed.When the operation was started, the flow rate was 1.1lpm and the proper flow rate.After watching the situation for a while, there was no change and tried holding the tube of the arctic gel pad by hand to see if flow rate could be reduced to about 0.2lpm, but it was difficult to adjust to around 0.2lpm and decreased to 0.0lpm and was displayed as stopped.After that, when direction of the arctic gel pad connector + and - marks, but currently no directions were specified and was able to reproduce the pointed out contents.When the +1 mark side of the arctic gel pad connector was connected to the white direction on the water injection line side and the flow rate was 0.2lpm.This operation was performed repeatedly to confirm that the flow rate changed from 0.2 to 1.1lpm depending on the connector orientation.
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Event Description
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It was reported that the neonatal arctic gel pad flow rate was 0.2 lpm and the water temperature would not increase and the patient's temperature dropped to 31.85 °c.The arctic gel pad was replaced due to low flow and after some time, error 74 (non-recoverable system error secondary outlet water temperature sensor out of range ¿ low resistances) appeared for 4 times.The arctic sun device switched to the substitute.In case that the connector to set an arctic gel pad to the main body rotated 180 degrees, it operated correctly so that the water flow was 1.1 lpm.The representative visited the hospital on the day and confirmed that the newborn cooling pad was connected to the arctic sun device and started using it.After using it, the flow rate of the arctic gel pad was only 0.2lpm, but since the body temperature decreasing towards the target temperature and the arctic gel pad was expensive, the user continued to use it.After some time, the body temperature reached 33.5c, but the flow rate was 0.2lpm, the heater control was applied and the water temperature would not warm and the body temperature continued to drop to 31.5c.After that, the water temperature was balanced with the body temperature, so the heater would not turn on but the body temperature would not drop any further.The user exchanged the arctic gel pad and the flow rate was 1.0 lpm and the normal operation was achieved.The combination of the container and the arctic gel pad was confirmed.When the operation was started, the flow rate was 1.1lpm and the proper flow rate.After watching the situation for a while, there was no change and tried holding the tube of the arctic gel pad by hand to see if flow rate could be reduced to about 0.2lpm, but it was difficult to adjust to around 0.2lpm and decreased to 0.0lpm and was displayed as stopped.After that, when direction of the arctic gel pad connector + and - marks, but currently no directions were specified and was able to reproduce the pointed out contents.When the +1 mark side of the arctic gel pad connector was connected to the white direction on the water injection line side and the flow rate was 0.2lpm.This operation was performed repeatedly to confirm that the flow rate changed from 0.2 to 1.1lpm depending on the connector orientation.
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Manufacturer Narrative
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The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (no original packaging present), neonatal arctic gel pad present.Visual inspection of the pad surface noted no obvious visible defects such as cuts or tears in the foam.Visual inspection of the clear connectors noted no visible chips or deformities at the ends of all connectors.A kink was present in one of the pad lines near the pad line connector.There was no fluid or air leakage noted from the pad.The pad hydrogel was intact.The original liner was in place on the returned sample.According to the test method the flow rate was found to be unacceptable for the returned pad in both orientations.(acceptable range > 2.4 l/min.M2).No hydrogel peeled off the pad when separated from the liner.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿belt temperatures too low after nip roller and heated section." 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: "indications for use ¿ the arctic sun® temperature management system is intended for monitoring and controlling patient temperature in adult and pediatric patients of all ages.Contraindications ¿ there are no known contraindications for the use of a thermoregulatory system.¿ do not place arcticgel¿ pads on skin that has signs of ulcerations, burns, hives or rash.¿ while there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities.Warning ¿ do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.Cautions ¿ federal law restricts this device to sale by or on the order of a physician.¿ this product is to be used by or under the supervision of trained, qualified medical personnel.¿ the clinician is responsible for determining the appropriateness of use of this device and the user settable parameters, including water temperature, for each patient.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.¿ 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 edema, diabetes, peripheral vascular disease, poor nutritional status or steroid or high dose vasopressor therapy.If accessible, examine the patient¿s skin under the arcticgel¿ pads often; especially those patients 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 bags or other firm positioning devices under the arcticgel¿ pads.Do not place any positioning devices under the pad manifolds or patient lines.¿ 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 directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ carefully remove arcticgel¿ pads from the patient¿s skin at the completion of use.Aggressive removal or removal of cold pads from the patient¿s skin may result in skin tears.¿ the arcticgel¿ pads are non-sterile for single patient use only.Do not place pads in the sterile field.If used in a sterile environment, pads should be placed according to the physician¿s directions, either prior to the sterile preparation or sterile draping.¿ do not reprocess or sterilize.¿ use pads immediately after opening.Do not store pads in opened pouch.¿ do not allow circulating water to contaminate the sterile field when lines are disconnected.¿ the arcticgel¿ pads should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.¿ if warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.¿ the arcticgel¿ pads are only for use with an arctic sun® temperature management system.¿ 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.¿ if needed, place defibrillation pads between the arcticgel¿ pads and the patient¿s skin.¿ discard used arcticgel¿ pads in accordance with hospital procedures for medical waste.Directions for use 1.Arcticgel¿ pads are only for use with an arctic sun® temperature management system control module.See operators manual for detailed instructions on system use.2.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the entire pad set.If the entire set of pads is not used, the minimum flow rate may not be achieved.3.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.4.Place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion.5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit.7.When finished, empty water from pads.Cold temperature increases the adhesiveness of the hydrogel.For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm.Slowly remove pads from the patient and discard." 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.
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