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

Catalog Number	317-00
Medical Device Problem Codes	Use of Device Problem (1670); Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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.
Event or Problem Description
It was reported that the patient on normothermia and it did not seem to be getting to targeted temperature (tt) in an arctic sun device.Targeted temperature (tt) was 35c, patient temperature (pt) was 33c, water temperature (wt) was 36.9-39.9c, flow rate (fr) was 2/5l/m.There was only alert ~7 hours earlier (alarm 15- unable to obtain a stable patient temperature).Patient weight was 99kg, pad size was m.Explained that without adequate pad coverage the patient might not reach the target temperature.If there was not proper pad coverage the water temperature (wt) might get too hot or cold to compensate.Based on patient's weight - the large pads might be a better fit (73-100kg).Discussed with inquirer how the device was functioning appropriately.Reminded rn to do diligent skin checks and call back with any questions.
Additional Manufacturer Narrative
Per additional information received, bd has determined that this mdr event is not reportable.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 normothermia and it did not seem to be getting to targeted temperature (tt) in an arctic sun device.Targeted temperature (tt) was 35c, patient temperature (pt) was 33c, water temperature (wt) was 36.9-39.9c, flow rate (fr) was 2/5l/m.There was only alert ~7 hours earlier (alarm 15- unable to obtain a stable patient temperature).Patient weight was 99kg, pad size was m.Explained that without adequate pad coverage the patient might not reach the target temperature.If there was not proper pad coverage the water temperature (wt) might get too hot or cold to compensate.Based on patient's weight - the large pads might be a better fit (73-100kg).Discussed with inquirer how the device was functioning appropriately.Reminded rn to do diligent skin checks and call back with any questions.Per follow up information received via email on 15jul2024, spoke with nurse who stated that they had decided to add one universal pad to the patient's abdomen instead of exchanging to a larger pad set.With the additional universal pad, the patient was able to meet target temperature as expected.Patient completed therapy with no further issues.All pads and probes had been disposed of.
Event or Problem Description
It was reported that the patient on normothermia and it did not seem to be getting to targeted temperature (tt) in an arctic sun device.Targeted temperature (tt) was 35c, patient temperature (pt) was 33c, water temperature (wt) was 36.9-39.9c, flow rate (fr) was 2/5l/m.There was only alert ~7 hours earlier (alarm 15- unable to obtain a stable patient temperature).Patient weight was 99kg, pad size was m.Explained that without adequate pad coverage the patient might not reach the target temperature.If there was not proper pad coverage the water temperature (wt) might get too hot or cold to compensate.Based on patient's weight - the large pads might be a better fit (73-100kg).Discussed with inquirer how the device was functioning appropriately.Reminded rn to do diligent skin checks and call back with any questions.Per follow up information received via email on 15jul2024, spoke with nurse who stated that they had decided to add one universal pad to the patient's abdomen instead of exchanging to a larger pad set.With the additional universal pad, the patient was able to meet target temperature as expected.Patient completed therapy with no further issues.All pads and probes had been disposed of.
Additional Manufacturer Narrative
Per additional information received, bd has determined that this mdr event is not reportable.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.

• 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: 19702482
• Report Number: 1018233-2024-04091
• Device Sequence Number: 3653851
• Product Code: DWJ
• UDI-Device Identifier: 00801741080005
• UDI-Public: (01)00801741080005
• 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,Followup
• Report Date (Section B): 08/13/2024

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
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/13/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/23/2024
• 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: 99 KG