MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; PEDIATRIC PADS

Catalog Number	318-01-04
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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.All available udi information is being provided.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 alerting 02 low flow.Patient temperature (pt) was 98.2f, targeted temperature (tt) was 98.6f, water temperature (wt) was 66.6f, water flow rate (wfr) was 0.9 l/m.1 small universal pad connected to 8 kilo pediatric patient.Nurse stated they are very small and there was no room for a second pad.Had stop therapy, empty and disconnect pad.Reconnected using proper technique.Restarted therapy and water flow rate (wfr) was stabilized at 0.2 l/m and would not increase.Had stop therapy, empty and disconnect.Placed device in manual control at 75f with no pads connected.System diagnostics showed that the outlet monitor temperature (t1) was 64.2f, outlet control temperature (t2) was 64.5f, inlet temperature (t3) was 65.7f, chiller temperature (t4) was 44.2f, water flow rate (wfr) was 1.7 l/m, inlet pressure (ip) was -7psi circulation pump command (cpc) was 49 percentage, mixing pump command (mpc) was 0, heater was 53, water reservoir level (wrl) was 5, system hours were 7439 and pump hours were 4700.3.Walked through disabling manual control.Reconnected pads and again water flow rate (wfr) would not rise above 0.2 l/m.Advised to swap out to a new pad.Low flow pad lot: ngkn1580.Per follow up information received via task on 25feb2026, spoke with nurse who confirmed they had placed the pad in the storage close and told to notify their supplies manager for pad return.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: PEDIATRIC PADS
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; suite 200; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; suite 200; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24475128
• Report Number: 1018233-2026-01365
• Device Sequence Number: 10126256
• Product Code: DWJ
• UDI-Device Identifier: 00801741080128
• UDI-Public: (01)00801741080128(17)261231(10)NGKN1580
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• 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): 05/15/2026

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: 318-01-04
• Device Lot Number: NGKN1580
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 8 KG