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It was reported that the arctic sun device had low flow during normothermia.The flow rate ranged from 0.8-1.0 lpm.The complainant noted that the patient developed skin lesions on the back of the head.No medical intervention reported.Additional information was received via ibc via email that the clinical staff performed pressure-relief techniques by performing more consistent short-interval positioning.Arctic sun therapy was also discontinued to avoid possible severe traumatic brain injury.The wound was exposed and regularly reevaluated and assessed.Clinical evaluation of photo: a localized, circular-shaped , purple colored, intact wound to the occiput was noted.The wound appeared well demarcated, with no visible edema or exudate.The skin surrounding the wound was slightly erythematous.Clinical evaluation of photo: a localized, circular shaped wound was noted with various discolorations: center was light tan surrounded by some erythema and pink colored tissue.There was no visible edema or exudate.Hair was apparent throughout the wound area.Per additional information received from the ibc , no ointments or medications were applied to the wound.The wound was reported to be healing and a foam dressing was recommended, but not "sensical" as the patient was "agile.".
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The reported event was inconclusive due to poor sample condition (unable to determine if patient reaction occurred because of returned sample).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 on one of the pad lines near the pad line connector.The original liner was in place on the returned sample.According to the test method the flow rate was found to be acceptable for the returned pad.(acceptable range > 2.4 l/min.M2).No hydrogel peeled off the pad when separated from the liner.A potential root cause for the reported failure could be, ¿materials that are contacting the patient¿s intact skin are not biocompatible.¿ the lot 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 a thermal regulating system, indicated 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 non-invasive thermoregulatory system.Do not place the neonatal arcticgel¿ pad on skin that has signs of ulcerations, burns, hives or rash.Do not remove the fabric release liner of the neonatal arcticgel¿ pad and expose the hydrogel.Do not place the neonatal arcticgel¿ pad hydrogel on immature (non-keratinized) skin or premature babies.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 the neonatal arcticgel¿ pad over transdermal medication patches as warming can increase drug delivery and cooling can reduce the 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.The neonatal arcticgel¿ pad is only for use with the arctic sun® temperature management system.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 usersettable parameters, including water temperature, for each patient.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, steroid use, or high dose vasopressor therapy.If accessible, examine the patient¿s skin under the neonatal arcticgel¿ pad 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 neonatal arcticgel¿ pad.Do not place any positioning devices under the pad manifolds or patient lines.If warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.Do not allow urine, stool, antibacterial solutions or other agents to pool underneath the neonatal arcticgel¿ pad.Urine, stool and antibacterial agents can absorb into the pad hydrogel and cause chemical injury, skin irritation, and loss of pad adhesion over time.Replace pads immediately if these fluids come into contact with the hydrogel.Do not place the neonatal arcticgel¿ pad directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.If needed, place defibrillation pads between neonatal arcticgel¿ pad and the patient¿s skin.The neonatal arcticgel¿ pad is 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.The neonatal arcticgel¿ pad should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.The neonatal arcticgel¿ pad must be replaced after 120 hours (5 days) of use.Do not allow circulating water to contaminate the sterile field when lines are disconnected.Discard used neonatal arcticgel¿ pad in accordance with hospital procedures for medical waste.Directions 1.Place the patient (1.8 - 4.5 kg; 4.0 - 9.9 lb) on the pad.Avoid placing the patients over the manifolds or other high pressure locations.The rate of temperature change and potentially the final achievable temperature is affected by pad surface area coverage, placement, patient size, and water temperature range.2.The pad surface must be contacting the skin for optimal energy transfer efficiency.A) if desired, the center section of the pad can be wrapped around the patient¿s torso and secured in place using the velcro tabs provided.If this option is in use, ensure that the edges of the pad are away from articulating areas of the body to avoid irritation.Place pads to allow for full respiratory excursion.(e.G.Ensure free movement of the chest and abdomen are guaranteed).¿ the pads may be removed and reapplied if necessary.Pads should be placed on healthy, clean skin only.3.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) and the potential for rapid patient temperature change, it is recommended to use the following settings to the arctic sun® temperature management system: water temperature high limit: =40°c (104°f) water temperature low limit: =10°c (50°f) control strategy: 2 4.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) it is recommended to use the patient temperature high and patient temperature low alert settings.5.Place a core patient temperature probe and connect to the arctic sun® temperature management system patient temperature 1 connector for continuous patient temperature feedback.A rectal or esophageal temperature probe is recommended.6.Verify patient core temperature with an independent temperature probe before and at regular intervals during use.7.Attach the pad¿s line connectors to the fluid delivery line manifolds.8.See arctic sun® temperature management system operators manual and help screens for detailed instructions on system use.9.Begin treating the patient.10.If the pad fails to prime or a significant continuous air leak is observed in the pad return line, check the connections, then if needed, replace the leaking pad.Once the pad is primed, assure the steady state flow rate displayed on the control panel is appropriate.The minimum flow rate should be 1.1 l/m.11.When finished, purge water from pad." correction: b2.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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It was reported that the arctic sun device had low flow during normothermia.The flow rate ranged from 0.8-1.0 lpm.The complainant noted that the patient developed skin lesions on the back of the head.Additional information was received via ibc via email on (b)(6) 2020 that the clinical staff performed pressure-relief techniques by performing more consistent short-interval positioning.Arctic sun therapy was also discontinued to avoid possible severe traumatic brain injury.The wound was exposed and regularly reevaluated and assessed.Clinical evaluation of photo attachment: a localized, circular-shaped , purple colored, intact wound to the occiput was noted.The wound appeared well demarcated, with no visible edema or exudate.The skin surrounding the wound was slightly erythematous.Clinical evaluation of photo attachment : a localized, circular shaped wound was noted with various discolorations: center was light tan surrounded by some erythema and pink colored tissue.There was no visible edema or exudate.Hair was apparent throughout the wound area.Per additional information received from the ibc on (b)(6) 2020, no ointments or medications were applied to the wound.The wound was reported to be healing and a foam dressing was recommended, but not "sensical" as the patient is "agile.".
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