MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN TEMPERATURE CABLE

Catalog Number	735-02
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
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.Initial reporter name: (b)(6).All available udi information is being provided.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 sounded an alarm every 10 minutes due to loss of control, it was unable to monitor the temperature.Per review of wo on 15sep2025, there was no patient involvement.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, d.Initial reporter name: (b)(6) hospital (b)(6).All available udi information is being provided.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 sounded an alarm every 10 minutes due to loss of control, it was unable to monitor the temperature.Per review of wo on 15sep2025, there was no patient involvement.Per sample evaluation results received via task on 01oct2025, it was reported that the chiller temperature (t4) did not cool down.Circulation pump was too weak.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is due to a failed temperature in cable.During evaluation, it was confirmed that the device was unable to monitor the temperature.Temperature in cable was replaced.T4 does not cool down.Mixing pump and circulation pump too weak.Pm performed.Mixing pump and circulation pump were replaced.Heater and drain valves were replaced.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr review is not required as the serial/lot number is unknown.No additional actions can be taken at this time.Corrections: b, d, e, f, h.Udi format updated with available product information per gudid.H11: sections 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 sounded an alarm every 10 minutes due to loss of control, it was unable to monitor the temperature.Per review of wo on 15sep2025, there was no patient involvement.Per sample evaluation results received via task on 01oct2025, it was reported that the chiller temperature (t4) did not cool down.Circulation pump was too weak.

• Brand Name: ARCTIC SUN TEMPERATURE CABLE
• Common Device Name: TEMPERATURE CABLE
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23064612
• Report Number: 1018233-2025-08161
• Device Sequence Number: 18653004
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/26/2025

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: 735-02
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 11/26/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/08/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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