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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09
Device Problem Air Leak (1008)
Patient Problem Hyperthermia (1909)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: ¿arcticgel¿ pads - instructions for use: the arctic sun® temperature management system is intended for monitoring and controlling patient temperature. 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 (64. 4°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 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. 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 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. ¿ (b)(4). Correction: weight. The device was not returned.
 
Event Description
It was reported that the device alerted that there was a low air leak. The hypothermia patient had been undergoing rewarming for the last 2 hours, and the flow rate had been 1. 4-1. 6 l/pm. The patient's temperature was 36. 6c, and the water temperature was 27. 2c. The inlet pressure was -2 psi, and the circulation pump was operating at 100%. Per troubleshooting, the pads were disconnected and reconnected, and the flow rate settled at 1. 5 l/pm. The complainant reported that the low air leak issue started after the patient was disconnected and reconnected after a ct. She also reported that all of the pads have tape around the connectors which the night nurse had added to help with the air leaks. The complainant was advised that the gel pads were damaged and should be replaced. Per follow up, therapy continued with no further issues after the pads were replaced.
 
Event Description
It was reported that the device alerted that there was a low air leak. The hypothermia patient had been undergoing rewarming for the last 2 hours, and the flow rate had been 1. 4-1. 6 l/pm. The patient's temperature was 36. 6c, and the water temperature was 27. 2c. The inlet pressure was -2 psi, and the circulation pump was operating at 100%. Per troubleshooting, the pads were disconnected and reconnected, and the flow rate settled at 1. 5 l/pm. The complainant reported that the low air leak issue started after the patient was disconnected and reconnected after a ct. She also reported that all of the pads have tape around the connectors which the night nurse had added to help with the air leaks. The complainant was advised that the gel pads were damaged and should be replaced. Per follow up, therapy continued with no further issues after the pads were replaced.
 
Manufacturer Narrative
The reported event was unconfirmed. Received 1 articgel pad kit for evaluation. The visual inspection noted that the energy connector of the left chest pad was slightly damaged; the rest of the pads showed no irregularities, no obvious defects or manufacturing issues. The pads were submitted to the flow rate test with the arctic sun machine model 2000. The pads were connected to the arctic sun machine model 2000 during 10 minutes, see details below: * right chest pad: a total of 3. 90 l/min m2 of flow rate were registered during the test. * left chest pad: a total of 3. 65 l/min m2 of flow rate were registered during the test. * right thigh pad: a total of 4. 14 l/min m2 of flow rate were registered during the test. *left thigh pad: a total of 3. 82 l/min m2 of flow rate were registered during the test. According to the test method, the flow rate was found to be acceptable on all the returned pads. The flow rate for this product must be above 2. 4 l/min m2. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: ¿arcticgel¿ pads - instructions for use the arctic sun® temperature management system is intended for monitoring and controlling patient temperature. 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 (64. 4°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 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. 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 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. ¿ (b)(4).
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard 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 bard. The device was not returned.
 
Event Description
It was reported that the device alerted that there was a low air leak. The hypothermia patient had been undergoing rewarming for the last 2 hours, and the flow rate had been 1. 4-1. 6 l/pm. The patient's temperature was 36. 6c, and the water temperature was 27. 2c. The inlet pressure was -2 psi, and the circulation pump was operating at 100%. Per troubleshooting, the pads were disconnected and reconnected, and the flow rate settled at 1. 5 l/pm. The complainant reported that the low air leak issue started after the patient was disconnected and reconnected after a ct. She also reported that all of the pads have tape around the connectors which the night nurse had added to help with the air leaks. The complainant was advised that the gel pads were damaged and should be replaced. Per follow up, therapy continued with no further issues after the pads were replaced.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTIC SUN GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7066923
MDR Text Key262506624
Report Number1018233-2017-06158
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 03/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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