MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTIC SUN GEL PADS

Catalog Number 317-09-02

Device Problems Break (1069); Restricted Flow rate (1248); Misconnection (1399)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 arctic sun device had a restricted flow rate of 0l/min.When initiating therapy.Mss advised the nurse to disconnect and reconnect using proper technique, and there was no improvement.The nurse then took off the fluid delivery line and ran diagnostics, reconnected pads one by one, and there was still no flow.The facility did not have an alternate device so they tried a new set of pads and the flow rate was still 0l/min.Per follow up, the patient was removed from the device and the device was sent to the biomed.It was later reported via ms&s data on (b)(6) 2019, biomed (b)(6) provided the pump hours as 891 and system hours as 1018.Per troubleshooting with ms&s, the biomed enabled manual control with the water temperature set to 4c for 30 minutes and then 40c.The water cooled and heated appropriately.With only the fluid delivery line attached, the flow rate was 1.8l/min, inlet pressure (ip) was -7psi, and circulation pump (cp) was 58%.The biomed checked the valve sets with a shunt tube and all had a flow rate greater than 3.7 l/min, ip of -7psi, and cp was 87-100%.The pads were then added sequentially.The first chest pad was attached, the flow rate was 0.9l/min, ip -7psi, and cp 39%.With the second chest pad attached, the flow rate was 1.8l/min, ip -7psi and cp= 58%.The first thigh pad was added and the flow rate was 2.6l/min, ip -7psi and cp=64%.The last thigh pad was then added, and the flow rate dropped to 0l/min, ip -4.3psi, and cp 100%.The biomed stated that the clamp catch on the blue side was broken, so the pad would not connect properly.Ms&s discussed how the device was working as expected with expected flow rate, ip, and cp with no pads attached.It was later reported via email from biomed (b)(6) on (b)(6) 2019, the second set of pads used on the device were returned to biomed for evaluation, as they could not get past the low flow error.

Manufacturer Narrative

The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (no original packaging present), large arctic gel pad kit present.All four pads were returned.Visual inspection of the pad surface noted no 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.Zippered sample container bags were adhered to the hydrogel of the returned pads to simulate a liner replacement.Each pad was individually tested according the test method, the flow rate was found to be acceptable for all returned pads.(acceptable range 2.4 l/min.M2).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 usersettable 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 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 maximum number and largest size pads.3.For patient comfort, the pads may be prewarmed 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 2.3 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.".

Event Description

It was reported that the arctic sun device had a restricted flow rate of 0l/min.When initiating therapy.Mss advised the nurse to disconnect and reconnect using proper technique, and there was no improvement.The nurse then took off the fluid delivery line and ran diagnostics, reconnected pads one by one, and there was still no flow.The facility did not have an alternate device so they tried a new set of pads and the flow rate was still 0l/min.Per follow up, the patient was removed from the device and the device was sent to the biomed.It was later reported via ms&s data on 20mar2019, biomed carl provided the pump hours as 891 and system hours as 1018.Per troubleshooting with ms&s, the biomed enabled manual control with the water temperature set to 4c for 30 minutes and then 40c.The water cooled and heated appropriately.With only the fluid delivery line attached, the flow rate was 1.8l/min, inlet pressure (ip) was -7psi, and circulation pump (cp) was 58%.The biomed checked the valve sets with a shunt tube and all had a flow rate greater than 3.7 l/min, ip of -7psi, and cp was 87-100%.The pads were then added sequentially.The first chest pad was attached, the flow rate was 0.9l/min, ip -7psi, and cp 39%.With the second chest pad attached, the flow rate was 1.8l/min, ip -7psi and cp= 58%.The first thigh pad was added and the flow rate was 2.6l/min, ip -7psi and cp=64%.The last thigh pad was then added, and the flow rate dropped to 0l/min, ip -4.3psi, and cp 100%.The biomed stated that the clamp catch on the blue side was broken, so the pad would not connect properly.Ms&s discussed how the device was working as expected with expected flow rate, ip, and cp with no pads attached.It was later reported via email from biomed carl on 22mar2019, the second set of pads used on the device were returned to biomed for evaluation, as they could not get past the low flow error.

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTIC SUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8506408
• MDR Text Key: 142202997
• Report Number: 1018233-2019-01915
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGCW2162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1