MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN FLUID DELIVERY LINE

Catalog Number	734-07
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse stated that the fluid delivery line (fdl) was improperly latched into place on the back of the arctic sun device and was unable to start therapy.Multiple nurses have tried to slide the silver lever to loosen the fluid delivery line (fdl), but it would not move.Confirmed the level should slide horizontally.Suggested having biomed come look at the device when they were in house later.No other devices available.
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.
Additional Manufacturer Narrative
The reported issue was inconclusive.At this time, the root cause of the reported event could not be determined.Multiple nurses have tried to slide the silver lever to loosen the fluid delivery line (fdl), but it would not move.Confirmed the level should slide horizontally.Suggested having biomed come look at the device when they were in house later.No other devices available.The instructions-for-use are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Connections 1) use only medivance approved cables and accessories with the arctic sun¿ temperature management system control module.Connect the fluid delivery line, patient temp 1 cable, patient temp 2 cable (optional) and fill tube to the back of the control module.2) plug the power cord into the wall outlet.Position arctic sun¿ temperature management system so that access to the power cord is not restricted.Connect arcticgel¿ pads while holding the pad line tubing, insert the clear pad line connector into the fluid delivery line manifold.Do not press or squeeze the wings when connecting.The connector will click into place.Check the surface of the device for mechanical damage prior to use.External surfaces ¿ clean the exterior body of the control module, fluid delivery lines, power cords and temperature cables using a soft cloth and mild detergent or disinfectant according to hospital protocol.Inspect fluid delivery line 1.Power on the system 2.From the patient therapy selection screen press the hypothermia button to display the hypothermia therapy screen.3.From the hypothermia therapy screen, press the manual control button to open the manual control window.4.Set the manual control water target temperature to 28°c and the duration to 30 minutes.5.Connect a shunt to a set of fluid delivery line ports.6.Press the help button and then press the help index button.Select the topic maintenance and service and sub topic system diagnostics then press the display button.Verify that inlet pressure is -7 ± 0.2.7.Repeat on all valves.If inlet pressure is out of range, replace the two valves that the shunt is connected to.8.Ensure that the shunt is removed before device is put back in service.A dhr review is not required as the serial number is unknown.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 fluid delivery line (fdl) was improperly latched into place on the back of the arctic sun device and was unable to start therapy.Multiple nurses have tried to slide the silver lever to loosen the fluid delivery line (fdl), but it would not move.Confirmed the level should slide horizontally.Suggested having biomed come look at the device when they were in house later.No other devices available.

• Brand Name: ARCTIC SUN FLUID DELIVERY LINE
• Common Device Name: ARCTIC SUN FLUID DELIVERY LINE
• 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: 21309569
• Report Number: 1018233-2025-00595
• Device Sequence Number: 18354887
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 03/17/2025

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: 734-07
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/18/2025
• 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