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

Catalog Number 50000000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/22/2023

Event Type  malfunction  

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.H3 other text : the device was not returned.

Event Description

It was reported that as per nurse patient was treating under an arctic sun device and should be normothermic.Targeted temperature was 98.6f (37c), patient temperature was 95.5f (35.278c), water temperature was 83.3f (28.5c) and water flow rate was 2.8 l/m.Four pads were attached.Rate set to 0.25c/hr.Patient was at 37c at midnight and removed from device.Placed back on device for 4 hours.Nurse denied any shivering, micro-shivering or seizure activity.Also confirmed good pad coverage.System diagnostics read outlet monitor temperature was 28.6c, outlet control temperature was 28.8c, inlet temperature was 28.7c, chiller temperature was 5.3c, water flow rate was 2.8 l/m, inlet pressure was -7 psi, circulation pump command was 66 percentage, mixing pump command was 0, heater was 22, water reservoir level was 5, system hours were 10,164 and pump hours were 9,188.Walked through stop therapy, drain pads and attempted to drain 16 ounces from right drain port.Nurse noted that no water was emptying from port, but mucous and red tinged substance were coming out.It was asked to try removing tube and replacing with same results.Advised to send device to biomed and swap out to another available device.It was asked to call back if additional assistance needed.Confirmed they would update cm/tm so that they could follow up with biomed & nurse educator at hospital.Spoke with them, they stated it could possibly be compressor oil or maintenance had not been done on the machine.

• 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: 18130718
• MDR Text Key: 328273627
• Report Number: 1018233-2023-08096
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 02/17/2024
• 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