MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Catalog Number	317-05-02
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
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: 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 during patient use, the arctic sun device had error 113 (reduced water temperature control) sounded, and the flow rate was low at 2.2 l/min.Health professional checked the connector section of the gel pad and found bubbles (air) had entered.To determine whether the cause was on the main unit side or the pad side, it was connected to the verification line, confirming it was the pad side.After reinstalling the pad connector onto the arctic sun unit, the air disappeared, and the flow rate increased to 3 l/min.Treatment continued as is to monitor the situation.Subsequently, a similar issue recurred approximately three hours later.Body temperature control was maintained, so patient treatment continued.After treatment completion, the responsible staff member visited while the health professional was performing a running check.To investigate the pad defect, the pad hose was stripped, revealing multiple locations where the tube was crushed.Further crushing of the tube during operation was observed.The storage box showed no abnormalities.It was unlikely the tube was crushed by contact with the patient, bed, or other peripheral equipment during treatment, raising concerns about a potential manufacturing defect.Information was requested regarding similar cases and the number of occurrences.The affected item has been discarded as it was used on a patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d.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 during patient use, the arctic sun device had error 113 (reduced water temperature control) sounded, and the flow rate was low at 2.2 l/min.Health professional checked the connector section of the gel pad and found bubbles (air) had entered.To determine whether the cause was on the main unit side or the pad side, it was connected to the verification line, confirming it was the pad side.After reinstalling the pad connector onto the arctic sun unit, the air disappeared, and the flow rate increased to 3 l/min.Treatment continued as is to monitor the situation.Subsequently, a similar issue recurred approximately three hours later.Body temperature control was maintained, so patient treatment continued.After treatment completion, the responsible staff member visited while the health professional was performing a running check.To investigate the pad defect, the pad hose was stripped, revealing multiple locations where the tube was crushed.Further crushing of the tube during operation was observed.The storage box showed no abnormalities.It was unlikely the tube was crushed by contact with the patient, bed, or other peripheral equipment during treatment, raising concerns about a potential manufacturing defect.Information was requested regarding similar cases and the number of occurrences.The affected item has been discarded as it was used on a patient.Per follow up information received via task on 17oct2025, the number of products affected (gel pad) was unknown.Sample was not available.No impact to the patient.The flow rate was unknown.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.The reported product number is unknown.The udi number for this product is not available.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 during patient use, the arctic sun device had error 113 (reduced water temperature control) sounded, and the flow rate was low at 2.2 l/min.Health professional checked the connector section of the gel pad and found bubbles (air) had entered.To determine whether the cause was on the main unit side or the pad side, it was connected to the verification line, confirming it was the pad side.After reinstalling the pad connector onto the arctic sun unit, the air disappeared, and the flow rate increased to 3 l/min.Treatment continued as is to monitor the situation.Subsequently, a similar issue recurred approximately three hours later.Body temperature control was maintained, so patient treatment continued.After treatment completion, the responsible staff member visited while the health professional was performing a running check.To investigate the pad defect, the pad hose was stripped, revealing multiple locations where the tube was crushed.Further crushing of the tube during operation was observed.The storage box showed no abnormalities.It was unlikely the tube was crushed by contact with the patient, bed, or other peripheral equipment during treatment, raising concerns about a potential manufacturing defect.Information was requested regarding similar cases and the number of occurrences.The affected item has been discarded as it was used on a patient.Per follow up information received via task on 17oct2025, the number of products affected (gel pad) was unknown.Sample was not available.No impact to the patient.The flow rate was unknown.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS
• 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 CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23200523
• Report Number: 1018233-2025-08775
• Device Sequence Number: 13051266
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067(11)250130(17)261031(10)NGJY4353
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 317-05-02
• Device Lot Number: NGJY4353
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 02/27/2026; 04/08/2026
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 03/04/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown