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It was reported that the baby had a subcutaneous fat necrosis on the back shoulder area.Territory manager checked with the team on both day and night shift during the 4 days when the product was used.And stated that the water temperature was warm for the entire 3 days and baby was calm.Manager was not sure of patient related issues that might have predisposed the baby to have this or if the nurse team did not turn enough.And was not convinced that this was caused by the product.Since it was just a water blanket, it likely would have been far worse, as it would have likely happened regardless.Per follow up email response received on 18april2022, it was stated that the therapy was completed on the patient.The subcutaneous fat necrosis was noted to bilateral (b/l) posterior scapular areas and descending to bilateral (b/l) flank regions.This was noticed after the therapy was stopped and it was contributed to the pad use and was pending a dermatology consultation.Medications that were given to the patient were ¿tpn/smof lipids, dilute morphine 0.18mg, and tylenol¿.The pad lot number was ngft3412, and no sample is available as the pads were thrown away.
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The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be ¿8.2.2 materials that are contacting the patient¿s intact skin are not biocompatible¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "the ifu currently instructs the user on the proper use of the product to avoid undue injury to the patient and damage to the product.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.Contraindications ¿ there are no known contraindications for the use of a non-invasive thermoregulatory system.¿ do not place the neonatal arctic gel¿ pad on skin that has signs of ulcerations, burns, hives or rash.¿ do not remove the fabric release liner of the neonatal arctic gel¿ pad and expose the hydrogel.¿ do not place the neonatal arctic gel¿ 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 arctic gel¿ 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 arctic gel¿ 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 user settable 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 arctic gel¿ 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 arctic gel¿ 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 arctic gel¿ 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 arctic gel¿ pad directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ if needed, place defibrillation pads between neonatal arctic gel¿ pad and the patient¿s skin.¿ the neonatal arctic gel¿ 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 arctic gel¿ pad should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.The neonatal arctic gel¿ 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 arctic gel¿ 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: g 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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It was reported that the baby had a subcutaneous fat necrosis on the back shoulder area.Territory manager checked with the team on both day and night shift during the 4 days when the product was used.And stated that the water temperature was warm for the entire 3 days and baby was calm.Manager was not sure of patient related issues that might have predisposed the baby to have this or if the nurse team did not turn enough.And was not convinced that this was caused by the product.Since it was just a water blanket, it likely would have been far worse, as it would have likely happened regardless.Per follow up email response received on (b)(6) 2022, it was stated that the therapy was completed on the patient.The subcutaneous fat necrosis was noted to bilateral (b/l) posterior scapular areas and descending to bilateral (b/l) flank regions.This was noticed after the therapy was stopped and it was contributed to the pad use and was pending a dermatology consultation.Medications that were given to the patient were ¿tpn/smof lipids, dilute morphine 0.18mg, and tylenol¿.The pad lot number was ngft3412, and no sample is available as the pads were thrown away.
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