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

Catalog Number 50000000

Device Problems Insufficient Heating (1287); Lack of Effect (4065)

Patient Problem Convulsion/Seizure (4406)

Event Date 07/24/2023

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 stated the patient temperature dropped and the arctic sun device alerted the low patient temperature.The patient temperature was 32.6c, target temperature was 33.5c and water temperature was 39.7c.The nurse noted and spoke with representative, they advised to disconnect and reconnect probe and temperature cable but no change.The nurse verified the connection between probe and cable and also between cable and device.Esophageal probe was in use and placement confirmed.Unable to plug probe into bedside monitor or alternate device and secondary probe correlates with the patient temperature at 32.4c.They discussed patient condition and seizure activity that occurred a few minutes before the patient temperature drop.Discussed medications that were administered.They noted device was responding appropriately to patient temperature drop and secondary source confirmed the patient temperature so the drop appears to be patient related.Call back with additional questions/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.H3 other text : the device was not returned.

Event Description

It was reported that the nurse stated the patient temperature dropped and the arctic sun device alerted the low patient temperature.The patient temperature was 32.6c, target temperature was 33.5c and water temperature was 39.7c.The nurse noted and spoke with representative, they advised to disconnect and reconnect probe and temperature cable but no change.The nurse verified the connection between probe and cable and also between cable and device.Esophageal probe was in use and placement confirmed.Unable to plug probe into bedside monitor or alternate device and secondary probe correlates with the patient temperature at 32.4c.They discussed patient condition and seizure activity that occurred a few minutes before the patient temperature drop.Discussed medications that were administered.They noted device was responding appropriately to patient temperature drop and secondary source confirmed the patient temperature so the drop appears to be patient related.Call back with additional questions/concerns.

Event Description

It was reported that the nurse stated the patient temperature dropped and the arctic sun device alerted the low patient temperature.The patient temperature was 32.6c, target temperature was 33.5c and water temperature was 39.7c.The nurse noted and spoked with representative, they advised to disconnect and reconnect probe and temperature cable but no change.The nurse verified the connection between probe and cable and also between cable and device.Esophageal probe was in use and placement confirmed.Unable to plug probe into bedside monitor or alternate device and secondary probe correlates with the patient temperature at 32.4c.They discussed patient condition and seizure activity that occurred a few minutes before the patient temperature drop.Discussed medications that were administered.They noted device was responding appropriately to patient temperature drop and secondary source confirmed the patient temperature so the drop appears to be patient related.Call back with additional questions/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.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: 17571464
• MDR Text Key: 321411640
• Report Number: 1018233-2023-06155
• 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,Followup
• Report Date: 01/19/2024

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: 07/24/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 01/19/2024
• Supplement Dates FDA Received: 10/30/2023; 01/22/2024
• 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