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

Catalog Number 317-07

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 07/04/2022

Event Type  malfunction  

Event Description

It was reported that they had a patient on arctic sun device who was cooled after an initial insult.Patient had now been rewarmed and was maintaining at normothermia.Nurse stated that the target temperature was 37c, this morning the patient was 37.2c, currently the patient temperature was 36.5c, water temperature was 31.6c.Nurse wanted to confirm that the device was working properly.Nurse did not understand why the water temperature was lower than the patient temperature if the patient was below target.Nurse stated that the trend was neutral, heater command was 12 percent, pump hours were 6923, system hours were 7797, flow rate was 2.7lpm, inlet pressure was -7psi, patient weighs 83kg, medium pads were in place.Nurse stated that pads had been on for 4 to 5 days and were not adhering well at this point.Nurse stated that foley probe was in place.There was some exposed abdomen.Mss explained that the device was responding appropriately.There was a 0.5c allowable tolerance.Mss explained 12 percent of heater command, and that if the water was a lot warmer the patient would rewarm too quick and potentially above 37c.Mss suggested seeing how long the patient would be on therapy and replaced the pads as needed.

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 they had a patient on arctic sun device who was cooled after an initial insult.Patient had now been rewarmed and was maintaining at normothermia.Nurse stated that the target temperature was 37c, this morning the patient was 37.2c, currently the patient temperature was 36.5c, water temperature was 31.6c.Nurse wanted to confirm that the device was working properly.Nurse did not understand why the water temperature was lower than the patient temperature if the patient was below target.Nurse stated that the trend was neutral, heater command was 12 percent, pump hours were 6923, system hours were 7797, flow rate was 2.7lpm, inlet pressure was -7psi, patient weighs 83kg, medium pads were in place.Nurse stated that pads had been on for 4 to 5 days and were not adhering well at this point.Nurse stated that foley probe was in place.There was some exposed abdomen.Mss explained that the device was responding appropriately.There was a 0.5c allowable tolerance.Mss explained 12 percent of heater command, and that if the water was a lot warmer the patient would rewarm too quick and potentially above 37c.Mss suggested seeing how long the patient would be on therapy and replaced the pads as needed.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "4.5.1 inadequate design of attachment method (i.E.Hydrogel or straps)".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: "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 entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.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 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).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.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." the device was not returned.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15051946
• MDR Text Key: 303815242
• Report Number: 1018233-2022-05593
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• 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