MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN STAT; ARCTIC SUN DEVICE

Catalog Number	60000000L
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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.The reported product number is unknown.The udi number for this product is not available.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 had the arctic sun device alerting 113 (reduced water temperature control).Patient was close to targeted temperature (tt), sn# (b)(6).Targeted temperature (tt) was 33.5f, patient temperature (pt) was 32.8c, water temperature (wt) was 31.9c, flow rate (fr) was 0.7l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 26 percentage, mixing pump command (mpc) was 0, heater command (hc) was 16 percentage.Had nurse disconnect the pads, rotate the connector, and reconnect the pad.Made sure tubing was straight and not kinked anywhere.After disconnecting and reconnecting flow rate (fr) had settled to 1l/m, water temperature (wt) was increased to 37c.Explained to nurse when the flow rate drops below 1 l/min, the heater capacity diminishes.When the flow rate drops below 0.5 l/min, the heater turns off.This was an adequate flow rate for a neonate pad, suggested they monitor flow rate in case it does drop.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, e, 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.
Event or Problem Description
It was reported that the nurse had the arctic sun device alerting 113 (reduced water temperature control).Patient was close to targeted temperature (tt), sn# (b)(6).Targeted temperature (tt) was 33.5f, patient temperature (pt) was 32.8c, water temperature (wt) was 31.9c, flow rate (fr) was 0.7l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 26 percentage, mixing pump command (mpc) was 0, heater command (hc) was 16 percentage.Had nurse disconnect the pads, rotate the connector, and reconnect the pad.Made sure tubing was straight and not kinked anywhere.After disconnecting and reconnecting flow rate (fr) had settled to 1l/m, water temperature (wt) was increased to 37c.Explained to nurse when the flow rate drops below 1 l/min, the heater capacity diminishes.When the flow rate drops below 0.5 l/min, the heater turns off.This was an adequate flow rate for a neonate pad, suggested they monitor flow rate in case it does drop.
Additional Manufacturer Narrative
The device was not returned.The reported issue was inconclusive.At this time, the root cause of the reported event could not be determined.Targeted temperature (tt) was 33.5f, patient temperature (pt) was 32.8c, water temperature (wt) was 31.9c, flow rate (fr) was 0.7l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 26 percentage, mixing pump command (mpc) was 0, heater command (hc) was 16 percentage.Had nurse disconnect the pads, rotate the connector, and reconnect the pad.Made sure tubing was straight and not kinked anywhere.After disconnecting and reconnecting flow rate (fr) had settled to 1l/m, water temperature (wt) was increased to 37c.Explained to nurse when the flow rate drops below 1 l/min, the heater capacity diminishes.When the flow rate drops below 0.5 l/min, the heater turns off.This was an adequate flow rate for a neonate pad, suggested they monitor flow rate in case it does drop.Per additional information received, received a call back from charge nurse, who confirmed no further issues with this device.The neonate pad was disposed of, and device remained in service without repair.The instructions-for-use were reviewed and 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 is not required as the device has undergone previous servicing and therefore the reported issue is not manufacturing related.Correction: b, d.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 had the arctic sun device alerting 113 (reduced water temperature control).Patient was close to targeted temperature (tt), sn# (b)(6).Targeted temperature (tt) was 33.5f, patient temperature (pt) was 32.8c, water temperature (wt) was 31.9c, flow rate (fr) was 0.7l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 26 percentage, mixing pump command (mpc) was 0, heater command (hc) was 16 percentage.Had nurse disconnect the pads, rotate the connector, and reconnect the pad.Made sure tubing was straight and not kinked anywhere.After disconnecting and reconnecting flow rate (fr) had settled to 1l/m, water temperature (wt) was increased to 37c.Explained to nurse when the flow rate drops below 1 l/min, the heater capacity diminishes.When the flow rate drops below 0.5 l/min, the heater turns off.This was an adequate flow rate for a neonate pad, suggested they monitor flow rate in case it does drop.Per follow up information received via task on 06may2025, received a call back from charge nurse, who confirmed no further issues with this device.The neonate pad was disposed of, and device remained in service without repair.

• Brand Name: ARCTIC SUN STAT
• 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: 21480149
• Report Number: 1018233-2025-01323
• Device Sequence Number: 3995248
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)220627
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• 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): 06/24/2025

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: 60000000L
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/21/2025; 06/24/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 03/25/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2022
• 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