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

Catalog Number	317-05
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient on therapy.Stopped to go to ct.Returned and they have been getting consistent 02 low flow & patient temperature (pt) was line open alerts in an arctic sun device.Adult patient.4 size small pads connected.Patient temperature (pt) was 37.4c, targeted temperature (tt) was 37c, water flow rate (wfr) was 0.3 l/m.Had them stop therapy, disconnect pads and place the device in manual control at 10c with no pads.System diagnostics, outlet monitor temperature (t1) was 12.8c, outlet control temperature (t2) was 12.7c, inlet temperature (t3) was 12.1c, chiller temperature (t4) was 8.8c, water flow rate (wfr) was 1.9 l/m, inlet pressure (ip) was -6.9psi, circulation pump command (cpc) was 55%, mixing pump command (mpc) was 100%, heater command (hc) was 0, water reservoir level (wrl) was 5, system hours were 5502.6, pump hours were 1646.9.Added pads to device while still in manual control water flow rate (wfr) was 1.6 l/m, inlet pressure (ip) was -1.4psi.Had them stop therapy and disabled manual control.Restarted therapy and water flow rate (wfr) was primed to 0 l/m.Advised to swap out the pads.They could have been damaged in transport or during ct.Sn (b)(6).
Additional Manufacturer Narrative
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 event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.A dhr could not be performed since no lot number was provided.Based on the results of the investigation no additional actions are required at this time.The instructions for use and labeling were reviewed and found to be adequate.All available udi information is being provided 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 patient on therapy, stopped to go to ct.Returned and they have been getting consistent 02 low flow & patient temperature (pt) was line open alerts in an arctic sun device.Adult patient.4 size small pads connected.Patient temperature (pt) was 37.4c, targeted temperature (tt) was 37c, water flow rate (wfr) was 0.3 l/m.Had them stop therapy, disconnect pads and place the device in manual control at 10c with no pads.System diagnostics, outlet monitor temperature (t1) was 12.8c, outlet control temperature (t2) was 12.7c, inlet temperature (t3) was 12.1c, chiller temperature (t4) was 8.8c, water flow rate (wfr) was 1.9 l/m, inlet pressure (ip) was -6.9psi, circulation pump command (cpc) was 55%, mixing pump command (mpc) was 100%, heater command (hc) was 0, water reservoir level (wrl) was 5, system hours were 5502.6, pump hours were 1646.9.Added pads to device while still in manual control water flow rate (wfr) was 1.6 l/m, inlet pressure (ip) was -1.4psi.Had them stop therapy and disabled manual control.Restarted therapy and water flow rate (wfr) was primed to 0 l/m.Advised to swap out the pads.They could have been damaged in transport or during ct.Sn (b)(6).

• 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 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 22890734
• Report Number: 1018233-2025-07036
• Device Sequence Number: 5802820
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• 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): 10/13/2025

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: 317-05
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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