MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE; ARCTIC SUN DEVICE

Catalog Number	718-00
Medical Device Problem Codes	Restricted Flow rate (1248); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the arctic sun device failed to regulate the temperature.Per sample evaluation results on (b)(6)2024, it was reported that the level sensor not detecting water level due to dirty water.Fill tube needed to be replaced.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The complete initial reporter customer name is (b)(6).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 arctic sun device failed to regulate the temperature.Per sample evaluation results on 01oct2024, it was reported that the level sensor not detecting water level due to dirty water.Fill tube needed to be replaced.Per wo updated on 07oct2024, it was noted that when they tried to fill the unit, there was no movement of the water from their bottle to the machine but there was normal noise coming from the pump.When they checked the filling tube trying to blow through it, that was impossible.Tried to clean/wash it with hot water and same results so they decided to change the tube.After that, the unit was filled without any problems.
Additional Manufacturer Narrative
It was found that 1018233-2024-06280 was not a bd complaint.Therefore, a retraction is being submitted.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE
• Common Device Name: ARCTIC SUN DEVICE
• 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: 20384946
• Report Number: 1018233-2024-06280
• Device Sequence Number: 6651920
• Product Code: DWJ
• UDI-Device Identifier: 00801741080197
• UDI-Public: (01)00801741080197
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K161602
• 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): 10/21/2024

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: 718-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown