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

Catalog Number 318-02

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the neonatal intensive care unit (nicu) nurse stated that they have already tried troubleshooting, but the flow rate (fr) was still 0.6lpm in an arctic sun device.Guided to system diagnostics showed that the system hours were 2096, pump hours were 2033, inlet pressure (ip) was -5.1psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0.6lpm.Disconnected and reconnected pads using proper technique.No change in values.Placed a towel between window on bed and tubing.Disconnected and rotated connector and rc.Still no change in values.Moved pad to sn (b)(6) and there was water spilling everywhere from the pad.Advised the pad would likely need to be replaced, but they tried on the other device just in case.Started therapy, system hours were 5753, pump hours were 5562, inlet pressure (ip) was -6.4psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 1.1lpm.Stopped therapy, drained and disconnected pad.Connected new pad lot number nggw4663 - they did not have the lot number for the old pad.Inlet pressure (ip) was -7psi, circulation pump command (cpc) was 36 percentage, flow rate (fr) was 1.3lpm.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.The potential root cause could be due to " improper material specifications for integrity of film (bonding capability) /improper material specifications for integrity of film (tear resistance)".The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "intended use the arctic sun® neonatal arcticgel¿ pads are intended for use with the arctic sun® temperature management system, to provide energy (heat) transfer between the patient and the temperature-controlled water circulating through the neonatal arcticgel¿ pads in order to provide targeted temperature management.Indications for use the arctic sun® temperature management system is athermal regulating system, indicated 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 non-invasive thermoregulatory system.¿ do not place the neonatal arcticgel¿ pad on skin that has signs of ulcerations, burns, hives or rash.¿ do not remove the fabric release liner of the neonatal arcticgel¿ pad and expose the hydrogel.¿ do not place the neonatal arcticgel¿ pad hydrogel on immature (non-keratinized) skin or premature babies.¿ 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 the neonatal arcticgel¿ pad over transdermal medication patches as warming can increase drug delivery and cooling can reduce the 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.¿ the neonatal arcticgel¿ pad is only for use with the arctic sun® temperature management system.¿ 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, steroid use, or high dose vasopressor therapy.If accessible, examine the patient¿s skin under the neonatal arcticgel¿ pad 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 neonatal arcticgel¿ pad.¿ do not place any positioning devices under the pad manifolds or patient lines.¿ if warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.¿ do not allow urine, stool, antibacterial solutions or other agents to pool underneath the neonatal arcticgel¿ pad.Urine, stool and antibacterial agents can absorb into the pad hydrogel and cause chemical injury, skin irritation, and loss of pad adhesion over time.Replace pads immediately if these fluids come into contact with the hydrogel.¿ do not place the neonatal arcticgel¿ pad directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ if needed, place defibrillation pads between neonatal arcticgel¿ pad and the patient¿s skin.¿ the neonatal arcticgel¿ pad is non-sterile for single patient use only.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.¿ the neonatal arcticgel¿ pads are for single patient use.Do not reprocess or sterilize.If used in a sterile environment, pads should be placed according to the physician¿s request, either prior to the sterile preparation or sterile draping.¿ use pads immediately after opening.¿ do not store pads in opened pouch.¿ the neonatal arcticgel¿ pad should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.¿ the neonatal arcticgel¿ pad must be replaced after 5 days of use.¿ do not allow circulating water to contaminate the sterile field when lines are disconnected.¿ discard used neonatal arcticgel¿ pad in accordance with hospital procedures for medical waste.Directions 1.Place the patient (1.8 - 4.5 kg; 4.0 - 9.9 lb) on the pad.Avoid placing the patients over the manifolds or other high pressure locations.The rate of temperature change and potentially the final achievable temperature is affected by pad surface area coverage, placement, patient size, and water temperature range.2.The pad surface must be contacting the skin for optimal energy transfer efficiency.A) if desired, the center section of the pad can be wrapped around the patient¿s torso and secured in place using the velcro tabs provided.¿ if this option is in use, ensure that the edges of the pad are away from articulating areas of the body to avoid irritation.¿ place pads to allow for full respiratory excursion.(e.G.Ensure free movement of the chest and abdomen are guaranteed).¿ the pads may be removed and reapplied if necessary.¿ pads should be placed on healthy, clean skin only.3.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) and the potential for rapid patient temperature change, it is recommended to use the following settings to the arctic sun® temperature management system: ¿ water temperature high limit: =40°c (104°f) ¿ water temperature low limit: =10°c (50°f) ¿ control strategy: 2 4.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) it is recommended to use the patient temperature high and patient temperature low alert settings.5.Place a core patient temperature probe and connect to the arctic sun® temperature management system patient temperature 1 connector for continuous patient temperature feedback.A rectal or esophageal temperature probe is recommended.6.Verify patient core temperature with an independent temperature probe before and at regular intervals during use.7.Attach the pad¿s line connectors to the fluid delivery line manifolds.8.See arctic sun® temperature management system operators manual and help screens for detailed instructions on system use.9.Begin treating the patient.10.If the pad fails to prime or a significant continuous air leak is observed in the pad return line, check the connections, then if needed, replace the leaking pad.Once the pad is primed, assure the steady state flow rate displayed on the control panel is appropriate.The minimum flow rate should be 1.1 l/m.11.When finished, purge water from pad.Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established." correction: d h11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the neonatal intensive care unit (nicu) nurse stated that they have already tried troubleshooting, but the flow rate (fr) was still 0.6lpm in an arctic sun device.Guided to system diagnostics showed that the system hours were 2096, pump hours were 2033, inlet pressure (ip) was -5.1psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0.6lpm.Disconnected and reconnected pads using proper technique.No change in values.Placed a towel between window on bed and tubing.Disconnected and rotated connector and rc.Still no change in values.Moved pad to sn dyaty063 and there was water spilling everywhere from the pad.Advised the pad would likely need to be replaced, but they tried on the other device just in case.Started therapy, system hours were 5753, pump hours were 5562, inlet pressure (ip) was -6.4psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 1.1lpm.Stopped therapy, drained and disconnected pad.Connected new pad lot number nggw4663 - they did not have the lot number for the old pad.Inlet pressure (ip) was -7psi, circulation pump command (cpc) was 36 percentage, flow rate (fr) was 1.3lpm.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18639553
• MDR Text Key: 334802324
• Report Number: 1018233-2024-00432
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other