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

Catalog Number 50000000

Device Problem Lack of Effect (4065)

Patient Problem Convulsion/Seizure (4406)

Event Date 11/16/2023

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 nurse called because they were in the rewarming phase and patient was having difficulty getting to the targeted temperature (tt).Noted that there were issues with patient temperature (pt) stability in the cooling phase as well, but the arctic sun device had been responding as expected to all temperature changes.Denied any alerts or alarms.Patient temperature (pt) was 34.7c, targeted temperature (tt) was 37c, water temperature (wt) was 38.8c, water flow rate (wfr) was 2.2 l/m.Rewarm rate set to 0.25c/hr.Began warming at 4pm.Confirmed patient had been having a large amount of seizure activity.Discussed medications administered.Nurse noted that they have determined patient temperature (pt) drop was patient related but wanted to see if they have any other suggestions for things they could do to assist with therapy.Verified they have confirmed patient temperature (pt) accuracy via 2 different temperature probes.No erratic temperature alerts so far.Discussed addition of bair huggers or warm blankets to hands, head and feet if applicable with protocol.Call back with any additional questions, concerns or alerts.It was unknown what medical intervention was provided.

Event Description

It was reported that the nurse called because they were in the rewarming phase and patient was having difficulty getting to the targeted temperature (tt).Noted that there were issues with patient temperature (pt) stability in the cooling phase as well, but the arctic sun device had been responding as expected to all temperature changes.Denied any alerts or alarms.Patient temperature (pt) was 34.7c, targeted temperature (tt) was 37c, water temperature (wt) was 38.8c, water flow rate (wfr) was 2.2 l/m.Rewarm rate set to 0.25c/hr.Began warming at 4pm.Confirmed patient had been having a large amount of seizure activity.Discussed medications administered.Nurse noted that they have determined patient temperature (pt) drop was patient related but wanted to see if they have any other suggestions for things they could do to assist with therapy.Verified they have confirmed patient temperature (pt) accuracy via 2 different temperature probes.No erratic temperature alerts so far.Discussed addition of bair huggers or warm blankets to hands, head and feet if applicable with protocol.Call back with any additional questions, concerns or alerts.It was unknown what medical intervention was provided.

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.However, this cannot be confirmed.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.The serial number is unknown; therefore, the device history record could not be reviewed.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." correction: h.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: 18274377
• MDR Text Key: 329834714
• Report Number: 1018233-2023-08763
• 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: 04/11/2024

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?: No
• 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: 11/16/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/12/2024
• 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): Other