MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES

Catalog Number	734-07
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse noted that the arctic sun device was leaking where the pad connects to the big grey hose.They think the manifold was cracked.They were not in the room.Explained this may cause flow rate issues, or a trip hazard for the family/hcps in the room.They can try another port to see if this resolves this issue, but if not, they may want to go ahead and replace the device.Had them go to the room to confirm flow rate and sn.Device was flowing at 2.7lpm.They will call for a new device.Per follow up information received via phone on 05jan2026, spoke with charge nurse who confirmed a biomed had received the device.No reported issues after device swap.Provided number for biomed.Called biomed who confirmed fluid delivery line was cracked.Stated it looked like it had been bent from poor storage, like the nurses bent or coiled it too tightly.They disposed of the fluid delivery line and ordered a new one.It has not arrived at this time.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause for the reported event is a failed fluid delivery line.They think the manifold was cracked.They were not in the room.Explained this may cause flow rate issues, or a trip hazard for the family hcps in the room.They can try another port to see if this resolves this issue, but if not, they may want to go ahead and replace the device.Had them go to the room to confirm flow rate and sn.Device was flowing at 2.7 lpm.They will call for a new device.Per follow up information received via phone on 05jan2026, spoke with charge nurse who confirmed a biomed had received the device.No reported issues after device swap.Provided number for biomed.Called biomed who confirmed fluid delivery line was cracked.Stated it looked like it had been bent from poor storage, like the nurses bent or coiled it too tightly.They disposed of the fluid delivery line and ordered a new one.It has not arrived at this time.A dhr review is not required as the batch number is unknown.The batch number for this investigation is unknown.The instructions for use were reviewed and found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Based on the results of the investigation, no additional actions are needed.Corrections: f, h.Udi format updated with available product information per gudid.H11: sections 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 or Problem Description
It was reported that the nurse noted that the arctic sun device was leaking where the pad connects to the big grey hose.They think the manifold was cracked.They were not in the room.Explained this may cause flow rate issues, or a trip hazard for the family hcps in the room.They can try another port to see if this resolves this issue, but if not, they may want to go ahead and replace the device.Had them go to the room to confirm flow rate and sn.Device was flowing at 2.7 lpm.They will call for a new device.Per follow up information received via phone on 05jan2026, spoke with charge nurse who confirmed biomed had received the device.No reported issues after device swap.Provided number for biomed.Called biomed who confirmed fluid delivery line was cracked.Stated it looked like it had been bent from poor storage, like the nurses bent or coiled it too tightly.They disposed of the fluid delivery line and ordered a new one.It has not arrived at this time.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Common Device Name: FLUID DELIVERY LINES
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24063338
• Report Number: 1018233-2026-00113
• Device Sequence Number: 10281908
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 734-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown