MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number 50000000

Device Problems Insufficient Cooling (1130); Lack of Effect (4065)

Patient Problems Chills (2191); Convulsion/Seizure (4406)

Event Date 07/23/2023

Event Type  Injury  

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.

Event Description

It was reported that the patient was on therapy for around 15 hours in arctic sun device.They had been getting alert 52 extended period of cold water consistently and then it has been alarming 53 prolonged cold-water exposure and stopping therapy every hour.The patient temperature are 38.7c, target temperature are 37c (ts foley) secondary temp (esophageal plugged into bedside monitor) 37.9c, water temperature are 5.6c 4 pads connected.The physician wanted therapy run on ts foley.They confirmed there was a small amount of exposed abdomen.The patient having seizure activity about every 12 hours and shivering.They had started the medication for shivering.Discussed counter warming per protocol to assist with shivering.They noted abdominal fat holds heat so adding a universal pad to the abdomen for additional coverage may assist with temperature control.Feel free to call back with any additional questions or concerns.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue is inadequate pharmaceutical delivery to suppress shivering.However, this cannot be confirmed.A dhr review is not required as the serial number is unknown.The instructions for use were found adequate and state the following: "the rate of temperature change and potentially the final achievable patient temperature is affected by many factors.Treatment application, monitoring and results are the responsibility of the attending physician.If the patient does not reach target temperature in a reasonable time or the patient is not able to be maintained at the target temperature, the skin may be exposed to low or high water temperatures for an extended period of time which may increase the risk for skin injury.Ensure that pad sizing/coverage and custom parameter settings are correct for the patient and treatment goals, refer to the arcticgel pad instructions for use for the appropriate flow rate.For patient cooling, ensure environmental factors such as excessively hot rooms, heat lamps, and heated nebulizers are eliminated and patient shivering is controlled.Otherwise, consider increasing minimum water temperature, modifying target temperature to an attainable setting or discontinuing treatment.For patient warming, consider decreasing maximum water temperature, modifying target temperature to an attainable setting or discontinuing treatment." 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 patient was on therapy for around 15 hours in arctic sun device.They had been getting alert 52 extended period of cold water consistently and then it has been alarming 53 prolonged cold-water exposure and stopping therapy every hour.The patient temperature are 38.7c, target temperature are 37c (ts foley) secondary temp (esophageal plugged into bedside monitor) 37.9c, water temperature are 5.6c 4 pads connected.The physician wanted therapy run on ts foley.They confirmed there was a small amount of exposed abdomen.The patient having seizure activity about every 12 hours and shivering.They had started the medication for shivering.Discussed counter warming per protocol to assist with shivering.They noted abdominal fat holds heat so adding a universal pad to the abdomen for additional coverage may assist with temperature control.Feel free to call back with any additional questions or concerns.Per follow up information received via email on 28aug2023, updated entry description (see attachment)no additional information or sample is available at this time.An additional follow up is not required.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• 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: 17571194
• MDR Text Key: 321408629
• Report Number: 1018233-2023-06150
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention