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

Catalog Number 50000000E

Device Problem Insufficient Heating (1287)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

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 patient should be rewarming on s/n (b)(6), but was cooling instead.Patient temperature 36.3c.Target temperature 37c.Water temperature 24.4c.Flow rate 2.5lpm.Patient was cooled to 36c for 24 hours and then began rewarming.The patient rewarmed earlier, but then dropped again.They stated to set the manual water temperature to 32c.They confirmed to enable manual control but it was not initiated.They thought the water should be 32c after making that adjustment.Event log has alert 116 (patient temperature change not detected), alert 11 (patient temperature below low patient alert) and alert 45 (ac power lost).Heater command 22%.Device reads to rewarm from 37c to 37c at 0.5c/hr.Device in normothermia.Got nurse to send an image of the screen.Discussed about the graph.Therapy was stopped during dayshift and device rewarmed from 34.5c.It appears target was set to 36.5c at that time.Patient warmed to 37c.Nurse stopped therapy when patient's temperature was decreasing to match 36.5c.Device rewarming patient from 36c.Explained dashed and solid yellow match, indicating patient was rewarming as the device was programmed.No further action needed at this time.Discussed alert 116.Confirmed probe connected to 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: 19115690
• MDR Text Key: 341250101
• Report Number: 1018233-2024-02121
• 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
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• 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