MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS; ARCTIC GEL PAD NEONATAL

Catalog Number 318-02-02

Device Problems Defective Device (2588); Deformation Due to Compressive Stress (2889); Improper Flow or Infusion (2954)

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

Event Date 05/10/2020

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 neonatal pad created a low flow incident several times however the treatment went fine for a long time and undershot target temperature by a bit.After the use of another pad the problem was resolved.2 days later the image of defective pad was received.The tube entrance at the pad site had a kink which had obstructed the flow.

Event Description

It was reported that the neonatal pad created a low flow incident several times, however, the treatment went fine for a long time and undershot target temperature by a bit.After the use of another pad the problem was resolved.2 days later the image of defective pad was received.The tube entrance at the pad site had a kink which had obstructed the flow.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Visual evaluation of the returned sample noted that one opened (no original packaging present), neonatal arctic gel pad kit.Visual inspection of the pad surface noted no obvious 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.Visual inspection of the tubing for the pad noted damaged pad line insulation and 3 significant kinks present in 3 of the pad lines near the pad line connectors (>50% occlusion each).The flow rate was found to be acceptable for the returned pad.(acceptable range > 2.4 l/min.M2).No hydrogel peeled off the pad when separated from the liner.Although the reported event was confirmed, the root cause could not be determined.A potential root cause of this failure could be due to ¿incorrect setup causing pad lines occlusion, e.G.Kinking." the device would not meet the specifications.The product intended to be used for the treatment purposes, and was influenced by the reported failure.The lot number was unknown, therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indications for use the arctic sun® temperature management system is a thermal 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 arctic gel¿ pad on skin that has signs of ulcerations, burns, hives or rash.¿ do not remove the fabric release liner of the neonatal arctic gel¿ pad and expose the hydrogel.¿ do not place the neonatal arctic gel¿ 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 arctic gel¿ 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 arctic gel¿ 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 usersettable 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 arctic gel¿ 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 arctic gel¿ 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 arctic gel¿ 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 arctic gel¿ pad directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ if needed, place defibrillation pads between neonatal arctic gel¿ pad and the patient¿s skin.¿ the neonatal arctic gel¿ pad is 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.¿ the neonatal arctic gel¿ pad should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.The neonatal arctic gel¿ pad must be replaced after 120 hours (5 days) of use.¿ do not allow circulating water to contaminate the sterile field when lines are disconnected.¿ discard used neonatal arctic gel¿ 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.".

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC GEL PAD NEONATAL
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10112221
• MDR Text Key: 194114749
• Report Number: 1018233-2020-03529
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 318-02-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1