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

Model Number 50000000

Device Problems Insufficient Heating (1287); Use of Device Problem (1670)

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

Event Date 01/15/2022

Event Type  malfunction  

Event Description

It was reported that the hypothermia patient at 36 c was rewarming on arctic sun device for 3 hours and the nurse felt the device was not making water hot enough to warm the patient. The patient temperature was 34. 9 c, water temperature was 27 c, flow rate was 2. 8 l/min and there was good pad coverage. The patient came in with a temperature in the range of 34 c range and not under crrt (continuous renal replacement therapy). The device was in normothermia mode and the nurse had just changed the target from 36 c to 37 c and changed the rewarm rate to maximum. The water temperature was now up to 39 c. Mss discussed about the dangers of fast warming. Nurse decided it would be best to restart warming/therapy under hypothermia mode. Mss walked nurse through setting device to rewarm from 35 c at 0. 25 c/ hour to 36c , which was their protocol rewarm rate. Mss recommended nurse to not keep changing the settings but call first if needed any assistance. The device could make warm water and it was responding appropriately to the changes in the patient temperature.

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13448095
• Report Number: 1018233-2022-00389
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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

• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sex: No Answer Provided
• Patient Weight: KG
• Patient Outcome(s): Other