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

Model Number 50000000

Device Problems Insufficient Heating (1287); Device Sensing Problem (2917)

Patient Problem Convulsion/Seizure (4406)

Event Date 06/16/2023

Event Type  Injury  

Event Description

It was reported that nurse wanted to verify arctic sun device is working correctly.The patient was cooled to target temperature by 12.20.They started rewarm at 4pm before they came on shift.The patient temperature hit the target temperature of 37c within 4 hours.The nurse stated per book rewarm should take 18 hours.They noted duration time keeps changing and therapy graph shows before they came on shift.When patient started rewarming the water temperature was warm, then patient temperature was increased, and water temperature got low.The nurse denies any current shivering, microshivering or seizures, but confirmed first shift report did state patient was having a lot of seizure activity and medication was administered.Also they noted once in awhile goes off like patient is choking and noted that without all of the data they can only speculate.Based on information provided it appears the patient may have started generating heat and potentially rewarmed too quickly based on patient related condition.The device tried to respond and drop water temperature to counteract rewarming too quickly and keep patient temperature within range.They verified rewarm settings rewarm from 35c at 0.25c/hr to 37c.They noted that with those temperatures and rates it should take 8 hours to rewarm patient not 18 and then device will maintain patient at the target temperature.The patient temperature currently 37.2c.They advised will reach out to cm to assist with patient data download once this patient's therapy is complete.The only way to definitively know what occurred since no call came from first shift.Device is currently trying to maintain patient temperature.They advised to call back with any additional questions or concerns.

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 nurse wanted to verify arctic sun device is working correctly.The patient was cooled to target temperature by 12.20.They started rewarm at 4pm before they came on shift.The patient temperature hit the target temperature of 37c within 4 hours.The nurse stated per book rewarm should take 18 hours.They noted duration time keeps changing and therapy graph shows before they came on shift.When patient started rewarming the water temperature was warm, then patient temperature was increased, and water temperature got low.The nurse denies any current shivering, microshivering or seizures, but confirmed first shift report did state patient was having a lot of seizure activity and medication was administered.Also they noted once in awhile goes off like patient is choking and noted that without all of the data they can only speculate.Based on information provided it appears the patient may have started generating heat and potentially rewarmed too quickly based on patient related condition.The device tried to respond and drop water temperature to counteract rewarming too quickly and keep patient temperature within range.They verified rewarm settings rewarm from 35c at 0.25c/hr to 37c.They noted that with those temperatures and rates it should take 8 hours to rewarm patient not 18 and then device will maintain patient at the target temperature.The patient temperature currently 37.2c.They advised will reach out to cm to assist with patient data download once this patient's therapy is complete.The only way to definitively know what occurred since no call came from first shift.Device is currently trying to maintain patient temperature.They advised 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.

• 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: 17277850
• MDR Text Key: 318566562
• Report Number: 1018233-2023-04958
• 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: 09/22/2023

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 Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/25/2023
• 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