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

Catalog Number	318-01
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that when treatment was started using two additional general-purpose small arctic gel pads, alarms 01 and 02 occurred frequently.The arctic sun device itself was suspected and replaced with another device in the hospital, but this did not change anything.The alarms stopped when the pad was replaced with one pad.Since blisters were found on the tip of the pad, it was determined that the pad was defective.It was unknown what medical intervention was provided.
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.Pfmea ra7600780, revision 22, was reviewed for this investigation.The reported event is addressed in step/item #24 with potential failure mode is "low flow / restricted due to overheating of materials during lamination process, water flow path compromised".Based on this review the risk is within the expected range.Baw7650746 revision 1 was reviewed for this investigation.The labeling is found to be adequate.Based on this review the risk is within the expected range.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A dhr could not be performed since no lot number was provided.Correction: d, f, 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 when treatment was started using two additional general-purpose small arctic gel pads, alarms 01 and 02 occurred frequently.The arctic sun device itself was suspected and replaced with another device in the hospital, but this did not change anything.The alarms stopped when the pad was replaced with one pad.Since blisters were found on the tip of the pad, it was determined that the pad was defective.It was unknown what medical intervention was provided.Per follow up information received via task on 14may2025, the tracking information when the sample was ready for the shipment.No medications have been administered to the patient.
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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.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 when treatment was started using two additional general-purpose small arctic gel pads, alarms 01 and 02 occurred frequently.The arctic sun device itself was suspected and replaced with another device in the hospital, but this did not change anything.The alarms stopped when the pad was replaced with one pad.Since blisters were found on the tip of the pad, it was determined that the pad was defective.It was unknown what medical intervention was provided.Per follow up information received via task on 14may2025, the tracking information when the sample was ready for the shipment.No medications have been administered to the patient.

• 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: 22047768
• Report Number: 1018233-2025-03644
• Device Sequence Number: 8908730
• Product Code: DWJ
• UDI-Device Identifier: 00801741080128
• UDI-Public: (01)00801741080128(11)240712(17)260430(10)NGJS1988
• 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): 06/18/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 318-01
• Device Lot Number: NGJS1988
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 06/18/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/05/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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