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

Catalog Number	734-07
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
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: 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 they were trying to fill the arctic sun device, and task appears to be "stuck." asked if they emptied pads first and they state they did not.Had them stop filling reservoir and emptied pads.Water reservoir level shows 3 at this time.When attempting to fill device it appears to be "stuck" again (the screen says filling, but no water moving into pads and message never disappeared from screen).Stopped task again and restarted therapy.Flow rate (fr) was 2lpm.Suggested having biomed check this issue after therapy was complete.Per follow up information received via phone on 07aug2025, transferred to floor director who confirmed this device had been transported to the biomed three weeks ago.They did not have any patient information to share and noted they were not familiar with the original complainant.They took the information to discuss with the charge nurse once they were available.Transferred to the biomed.Spoke with biomed who confirmed ordering a new circulation pump for this device.They also noted a clog in the fluid delivery line (fdl).The biomed completed a total drain and cleaning of the device.After pump installation, device was returned to service.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause for the reported issue is a blockage in the fluid delivery line.Asked if they emptied pads first and they state they did not.Had them stop filling reservoir and emptied pads.Water reservoir level shows 3 at this time.When attempting to fill device it appears to be "stuck" again (the screen says filling, but no water moving into pads and message never disappeared from screen).Stopped task again and restarted therapy.Flow rate (fr) was 2lpm.Suggested having biomed check this issue after therapy was complete.Per follow up information received via phone on 07aug2025, transferred to floor director who confirmed this device had been transported to the biomed three weeks ago.They did not have any patient information to share and noted they were not familiar with the original complainant.They took the information to discuss with the charge nurse once they were available.Transferred to the biomed.Spoke with biomed who confirmed ordering a new circulation pump for this device.They also noted a clog in the fluid delivery line (fdl).The biomed completed a total drain and cleaning of the device.After pump installation, device was returned to service.A dhr review is not required as the lot number is unknown.The lot number for this investigation is unknown.The latest labeling revision will be reviewed for this investigation.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.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 they were trying to fill the arctic sun device, and task appears to be "stuck." asked if they emptied pads first and they state they did not.Had them stop filling reservoir and emptied pads.Water reservoir level shows 3 at this time.When attempting to fill device it appears to be "stuck" again (the screen says filling, but no water moving into pads and message never disappeared from screen).Stopped task again and restarted therapy.Flow rate (fr) was 2lpm.Suggested having biomed check this issue after therapy was complete.Per follow up information received via phone on 07aug2025, transferred to floor director who confirmed this device had been transported to the biomed three weeks ago.They did not have any patient information to share and noted they were not familiar with the original complainant.They took the information to discuss with the charge nurse once they were available.Transferred to the biomed.Spoke with biomed who confirmed ordering a new circulation pump for this device.They also noted a clog in the fluid delivery line (fdl).The biomed completed a total drain and cleaning of the device.After pump installation, device was returned to service.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Common Device Name: FLUID DELIVERY LINES
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; suite 200; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22772212
• Report Number: 1018233-2025-06657
• Device Sequence Number: 13155358
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/10/2025

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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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