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

Model Number 50000000E

Device Problem Insufficient Cooling (1130)

Patient Problems Paralysis (1997); Convulsion/Seizure (4406); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2022

Event Type  Injury  

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 nurse was getting an alert 52 (extended period of cold water) on the arctic sun device.Nurse stated the target temperature was 33 to 36c and this patient was set to 33c.Patient temperature was 34.7c, water temperature was 5.3c and flow rate was 3.1lpm.Patient started cooling yesterday, but they were unsure when.Cooling duration still read 24 hours.Patient weighed 100 kilograms.Nurse was unable to locate pad size, but confirmed they fit well.Mss discussed causes of heat generation.Nurse stated patient was sedated and paralyzed.There were no signs of infection.Patient was having seizure activity yesterday.Mss discussed benefits of counter warming and suggested discussing case with doctor to identify heat generation and whether target temperature was appropriate for this patient.Mss advised nurse to be diligent with skin checks.Nurse was just confirming there was nothing mechanically wrong with the device.

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.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.It is unknown if the device met specifications and whether the device was influenced by the reported failure.The device was in use on a patient.The dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.Based on the results of the investigation, no additional actions are needed.The instructions for use were found adequate and state the following: "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, water flow is greater than or equal to 2.3 liters per minute and the patient temperature probe is in the correct place.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." 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 was getting an alert 52 (extended period of cold water) on the arctic sun device.Nurse stated the target temperature was 33 to 36c and this patient was set to 33c.Patient temperature was 34.7c, water temperature was 5.3c and flow rate was 3.1lpm.Patient started cooling yesterday, but they were unsure when.Cooling duration still read 24 hours.Patient weighed 100 kilograms.Nurse was unable to locate pad size, but confirmed they fit well.Mss discussed causes of heat generation.Nurse stated patient was sedated and paralyzed.There were no signs of infection.Patient was having seizure activity yesterday.Mss discussed benefits of counter warming and suggested discussing case with doctor to identify heat generation and whether target temperature was appropriate for this patient.Mss advised nurse to be diligent with skin checks.Nurse was just confirming there was nothing mechanically wrong with the device.

• 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: 15209234
• MDR Text Key: 297687028
• Report Number: 1018233-2022-06292
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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
• Patient Weight: 100 KG