MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; ARCTIC GEL PADS

Catalog Number 317-07-I

Device Problem Biocompatibility (2886)

Patient Problems Irritation (1941); Skin Discoloration (2074); No Code Available (3191); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient experienced skin irritation while under therapy on arctic sun device.It was also reported that under clinical observation, the skin reaction had recovered completely.However, the final relation was unclear and could be possibly associated with cooling of device or medical treatment.Per follow-up with clinical affairs team on 16nov2020, initially a reddening of the skin was observed.It was also reported that the adverse event was resolved completely on (b)(6) 2020.Therapy on the arctic sun device was stopped on (b)(6) 2020 but the device was not swapped.It was further stated that therapy was completed using the same arctic gel pads.Per follow-up with clinical affairs team on 19nov2020, it was further reported that the patient experienced reddening of the skin on the whole body trunk, under the pads and also outside of the pads.Urapidil, ampicillin/sulbactam and metoprolol were administered to the patient on the onset of the event.

Event Description

It was reported that the patient experienced the skin irritation while under therapy on the arctic sun device.Also reported that under clinical observation the skin reaction was recovered completely.However the final relation was unclear and could be possibly associated with cooling of the device or medical treatment.Per follow up with clinical affairs team on 16nov2020 initially a reddening of the skin was observed.It was also reported that the adverse event was resolved completely on 01sep2020.The therapy on the arctic sun device was stopped on 30aug2020 but the device was not swapped.It was further stated that the therapy was completed using the same arctic gel pads.Per follow up with clinical affairs team on 19nov2020 it was further reported that the patient experienced reddening of the skin on the whole body trunk under the pads and also outside the pads.Urapidil ampicillin sulbactam and metoprolol were administered to the patient on the onset of the event.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to incorrect material selection.It was unknown whether the device had met specifications.The product used for the treatment but 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: "indications for use: 1) the arctic sun temperature management system is intended for monitoring and controlling patient temperature in adult and pediatric patients of all ages.Contraindications: 1) there are no known contraindications for the use of a thermoregulatory system.2) do not place arcticgel pads on skin that has signs of ulcerations, burns, hives or rash.3) 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: 1) do not place arcticgel pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.Cautions: 1) federal law restricts this device to sale by or on the order of a physician.2) this product is to be used by or under the supervision of trained, qualified medical personnel.3) the clinician is responsible for determining the appropriateness of use of this device and the user settable parameters, including water temperature, for each patient.4) 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.5) 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.6) 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.7) do not place arcticgel pads directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.8) 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.9) 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.10) do not reprocess or sterilize.11) use pads immediately after opening.Do not store pads in opened pouch.12) do not allow circulating water to contaminate the sterile field when lines are disconnected.13) the arcticgel pads should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.14) if warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.15) the arcticgel pads are only for use with an arctic sun temperature management system.16) 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.17) if needed, place defibrillation pads between the arcticgel pads and the patient¿s skin.18) 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 pre warmed 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." the device was not returned.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 10962974
• MDR Text Key: 220161559
• Report Number: 1018233-2020-21492
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 317-07-I
• Device Lot Number: NGEQ1126
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 75