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

Catalog Number	734-07
Medical Device Problem Codes	Restricted Flow rate (1248); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
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) 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 they were trying to start therapy on a patient.The arctic sun device was alarming the reservoir was empty.They were trying to fill the device, but it was not taking up any water.Confirmed fill tube was connected to the correct fill port.Nurse stated that the pads are connected, they had tried it with and without the pads connected.Had nurse disconnect the pads and try filling reservoir.Device still not taking up water, nurse could not hear the device running like it was trying to fill.Had nurse try removing the fluid delivery line (fdl) to see if they were able to feel the suction, but nurse unable to get fluid delivery line (fdl) off.Informed nurse to send this device to biomed for evaluation and switch to another device.
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 they were trying to start therapy on a patient.The arctic sun device was alarming the reservoir was empty.They were trying to fill the device, but it was not taking up any water.Confirmed fill tube was connected to the correct fill port.Nurse stated that the pads are connected, they had tried it with and without the pads connected.Had nurse disconnect the pads and try filling reservoir.Device still not taking up water, nurse could not hear the device running like it was trying to fill.Had nurse try removing the fluid delivery line (fdl) to see if they were able to feel the suction, but nurse unable to get fluid delivery line (fdl) off.Informed nurse to send this device to biomed for evaluation and switch to another device.Per follow up information received via task on 28may2025, spoke with biomed who confirmed they replaced the fdl, and the device worked without issue.They did not inspect it, but there might have been a minor hole in the tube causing air to enter.The fdl had been disposed of.
Event or Problem Description
It was reported that the nurse stated that they were trying to start therapy on a patient.The arctic sun device was alarming the reservoir was empty.They were trying to fill the device, but it was not taking up any water.Confirmed fill tube was connected to the correct fill port.Nurse stated that the pads are connected, they had tried it with and without the pads connected.Had nurse disconnect the pads and try filling reservoir.Device still not taking up water, nurse could not hear the device running like it was trying to fill.Had nurse try removing the fluid delivery line (fdl) to see if they were able to feel the suction, but nurse unable to get fluid delivery line (fdl) off.Informed nurse to send this device to biomed for evaluation and switch to another device.Per follow up information received via task on 28may2025, spoke with biomed who confirmed they replaced the fdl, and the device worked without issue.They did not inspect it, but there might have been a minor hole in the tube causing air to enter.The fdl had been disposed of.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause for the reported event is a failed fluid delivery line.Confirmed fill tube was connected to the correct fill port.Nurse stated that the pads are connected, they had tried it with and without the pads connected.Had nurse disconnect the pads and try filling reservoir.Device still not taking up water, nurse could not hear the device running like it was trying to fill.Had nurse try removing the fluid delivery line (fdl) to see if they were able to feel the suction, but nurse unable to get fluid delivery line (fdl) off.Informed nurse to send this device to biomed for evaluation and switch to another device.Per follow up information received via task on 28may2025, spoke with biomed who confirmed they replaced the fdl, and the device worked without issue.They did not inspect it, but there might have been a minor hole in the tube causing air to enter.The fdl had been disposed of.The lot number is unknown.The latest labeling revision will be reviewed for this investigation.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.A dhr review is not required as the lot number is unknown.Corrections: d, f, g, h.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 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 CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21858879
• Report Number: 1018233-2025-02761
• Device Sequence Number: 7888871
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/08/2025

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: 04/13/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 08/08/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/11/2025
• 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