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

Catalog Number 318-02

Device Problem Misassembly by Users (3133)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

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 neonate was cooling to 33.5c on arctic sun device since 1 pm today.Nurse reported that the patient temperature keeps dropping below target and the water was not getting warmer.The patient temperature was 31.9c, water temperature was 35.5c and the flow rate was 0.8l/ min.Neonate tacoed in pad.Event log showed multiple alert 113 (reduced water temperature control) and high water limit was 40c.Enabled manual control and set water temperature to 40c to check heater.Reservoir level was 5.Walked nurse through draining 500 mls of water from right drain port, then water temperature rose up to 40c.Disabled manual control and restarted therapy.Nurse disconnected and reconnected the arctic gel pad holding behind clear clamps, then the flow rate stabilized at 1.2l/min.Patient temperature was upto 32.2c by the end of the call.Recommended to change out device if there are further alerts/alarms.

Event Description

It was reported that the neonate was cooled to 33.5 c in the arctic sun device.The nurse stated that the patient temperature was dropping below the target and the water was not getting warmer.The patient temperature was 31.9 c the water temperature was 35.5 c and the flow rate was 0.8 lpm.The neonate tacoed in the pad and the event log showed multiple alerts 113 (reduced water temperature control) and high water limit was 40 c.The nurse enabled a manual control and set the water temperature to 40 c to check the heater.The reservoir level was 5.Ms and s walked through the nurse draining 500 ml of water from the right drain port then the water temperature raised up to 40 c.The nurse disabled the manual control and restarted the therapy.The nurse disconnected and reconnected the arctic gel pad holding behind the clear clamps then the flow rate was stabilized at 1.2 lpm.The patient temperature was 32.2 c by the end of the call.Ms and s are recommending the nurse to change out the device if there were further alerted or alarms.

Manufacturer Narrative

The reported event was confirmed as a use related.The root cause of this failure mode was misconnection of supply and return lines.The device had failed to meet the specifications due to the user.The product was used for diagnostic and treatment purposes.The failure was caused by the misuse of the product.The device history record review was not required due to the reported issue was confirmed as a use related.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.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 physicians 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 entire pad set.If the entire set of pads is not used, the minimum flow rate may not be achieved.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 1.7 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." 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.H3 other text : the device was not returned.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: NEONATAL ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11367219
• MDR Text Key: 233277631
• Report Number: 1018233-2021-00726
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 318-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other