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Catalog Number 317-07
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2019
Event Type  malfunction  
Manufacturer Narrative
The reported event could not be confirmed. No sample was returned for evaluation. A potential failure mode could be" pouch integrity is compromised ", a potential root cause for this failure could be " inadequate packaging stability". The device was not returned for evaluation. 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 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: arcticgel¿ pads are only for use with an arctic sun® temperature management system control module. See operators manual for detailed instructions on system use. 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 maximum number and largest size pads. For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application. 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. 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. Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2. 3 liters per minute, which is the minimum flow rate for a full pad kit. 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. ".
Event Description
It was reported that there was low flow on the arctic sun device and the hydrogel was dry after 48 hours of therapy. The flow rate was around 0. 9l/min. Hanging the pads resolved the issue.
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Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
MDR Report Key8896430
MDR Text Key161781996
Report Number1018233-2019-04737
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number317-07
Device Lot NumberNGDP3685
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial