MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Catalog Number	317-02-02
Medical Device Problem Codes	Defective Component (2292); Gas/Air Leak (2946)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/06/2024
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.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 peeling of the sticky portion of the arctic gel pads were noted twice on two different patients months ago but did not affect therapy as noted on the arctic sun device from recollection of feedback.Recently today, a patient using an xxs small was noted to have a chest pad that continuously had the audible sound of water rushing in (similar to when pads are first connected and fill however, this was continuous).It was not leaking, and the patient was therapeutic per review of the arctic sun.They tried draining the pads, disconnecting this pad specifically, reconnecting and restarting therapy but it did not resolve.Then changed out the pad and that resolved.
Additional Manufacturer Narrative
The root cause of the reported issue is a damaged pad connector.Visual evaluation of the returned sample noted one opened arctic gel xx small left chest pad present with no original packaging.Visual inspection noted the following: * no obvious visible defects such as cuts or tears in the foam.* the (+) end of the pad connector was found chipped and the tab was crooked.This damage to the connector would cause an air leak.* major kinks seen on the pad side of the lines.* hydrogel was intact with pad and not separated.* no crushed dimples or signs of overlamination in the pads.The reported issue could not be verified without further testing.The sample does not meet specifications per inspection procedure, which states "missing or damaged components are not allowed (the plastic film, foam or hydrogel, connector and tubes shall be free of damages, tears or perforations)".A review of the device history record and manufacturing controls did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad." correction: d, f, h 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 peeling of the sticky portion of the arctic gel pads were noted twice on two different patients months ago but did not affect therapy as noted on the arctic sun device from recollection of feedback.Recently today, a patient using an xxs small was noted to have a chest pad that continuously had the audible sound of water rushing in (similar to when pads are first connected and fill however, this was continuous).It was not leaking, and the patient was therapeutic per review of the arctic sun.They tried draining the pads, disconnecting this pad specifically, reconnecting and restarting therapy but it did not resolve.Then changed out the pad and that resolved.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS
• 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: 18992846
• Report Number: 1018233-2024-01642
• Device Sequence Number: 15354718
• Product Code: DWJ
• UDI-Device Identifier: 10801741080026
• UDI-Public: (01)10801741080026
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/22/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 317-02-02
• Device Lot Number: NGHS3411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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