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

Catalog Number	317-00-04
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
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 the nurse stated that the patient has been on therapy for a while, but now there was no water flow in an arctic sun device.Had customer restart therapy and guided to diagnostics showed that the system hours were 2439, pump hours were 1960, inlet pressure (ip) was -7, circulation pump command (cpc) was 42 percentage, flow rate (fr) was 1.5lpm.Confirmed they already tried disconnecting and reconnecting pads prior to the call.This might have resolved the flow rate (fr) issue.Patient had four universal pads on (nurse was unsure why it was done this way).Patient was 64kg.Suggested adding a universal pad to the abdomen for greater flow rate (fr) was and better pad coverage.Added universal pad and flow rate (fr) was increased to 2.2lpm, inlet pressure (ip) was -7.3, circulation pump command (cpc) was 51 percentage.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The dhr review could not be performed without a lot number.The labeling is found to be adequate.Directions for use: 1.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.2.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).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 stated that the patient has been on therapy for a while, but now there was no water flow in an arctic sun device.Had customer restart therapy and guided to diagnostics showed that the system hours were 2439, pump hours were 1960, inlet pressure (ip) was -7, circulation pump command (cpc) was 42 percentage, flow rate (fr) was 1.5lpm.Confirmed they already tried disconnecting and reconnecting pads prior to the call.This might have resolved the flow rate (fr) issue.Patient had four universal pads on (nurse was unsure why it was done this way).Patient was 64kg.Suggested adding a universal pad to the abdomen for greater flow rate (fr) was and better pad coverage.Added universal pad and flow rate (fr) was increased to 2.2lpm, inlet pressure (ip) was -7.3, circulation pump command (cpc) was 51 percentage.Per follow up information received via task on 12nov2024, charge nurse who noted another universal pad had been added and there were no further issues with flow.The reason they used universal pads instead was because they were out of size large pads and needed to order more.Pads were disposed of after therapy completed.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL 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, GA 30014 ; 7707846100
• MDR Report Key: 20077541
• Report Number: 1018233-2024-05212
• Device Sequence Number: 11512709
• Product Code: DWJ
• UDI-Device Identifier: 10801741080002
• UDI-Public: (01)10801741080002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/21/2024

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: 317-00-04
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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
• Patient Weight: 64 KG