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

Catalog Number	734-07
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse was walking by their arctic sun machine and noticed the fluid delivery line (fdl) was ripped in half.Nurse asked how to go about replacing it.Informed nurse they could order a replacement fluid delivery line (fdl) for the device.Suggested whoever orders their supplies, such as materials management.Or suggested sending it to biomed and having them order a replacement.Nurse would put in a work order for biomed to replace the fluid delivery line (fdl).
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 device was not returned.The reported issue was inconclusive.At this time, the root cause of the reported event could not be determined.Nurse asked how to go about replacing it.Informed nurse they could order a replacement fluid delivery line (fdl) for the device.Suggested whoever orders their supplies, such as materials management.Or suggested sending it to biomed and having them order a replacement.Nurse would put in a work order for biomed to replace the fluid delivery line (fdl).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.A dhr review is not required as the lot/serial number is unknown.Correction: g, h.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.
Event or Problem Description
It was reported that the nurse was walking by their arctic sun machine and noticed the fluid delivery line (fdl) was ripped in half.Nurse asked how to go about replacing it.Informed nurse they could order a replacement fluid delivery line (fdl) for the device.Suggested whoever orders their supplies, such as materials management.Or suggested sending it to biomed and having them order a replacement.Nurse would put in a work order for biomed to replace the fluid delivery line (fdl).

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINE
• Common Device Name: FLUID DELIVERY LINE
• 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, GA 30014 ; 7707846100
• MDR Report Key: 21856937
• Report Number: 1018233-2025-02730
• Device Sequence Number: 4720987
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/11/2025

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: 04/14/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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