MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number 50000000

Device Problems Use of Device Problem (1670); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2023

Event Type  malfunction  

Event Description

It was reported that rewarming patient for some time and patient was not getting to target temperature.Splice wire to monitor showed patient temperature was 97.7f in an arctic sun device patient temperature was 97.5f, target temperature was 98.6f.Water temperature had been 106 to 107 since 8pm.Nurse stated device alerted about temperature and wanted to make sure everything was ok.Noted minor discrepancy between monitor and arctic sun was normal.Only 0.1c degree difference and arctic sun temperature was what manages water temperature.Walked through accessing event log which shows device alarmed 115 (extended period of warm water) prolonged warm water exposure and alarm 14.Explained alarms.Nurse confirmed they unplugged probe when alarm 14 (patient temperature 1 probe out of range probe out of range) occurred.Confirmed patient has about 3+ inches of exposed abdomen.Encouraged them to add universal pad to abdomen.Discussed medications and effects on patient temperature especially in rewarming.Noted alarm 115 (extended period of warm water) encourages diligent skin checks according to protocol because of prolonged exposure to those higher water temperature.

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.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: 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 30014 ; 7707846100
• MDR Report Key: 18493503
• MDR Text Key: 333201811
• Report Number: 1018233-2024-00086
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other