MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a hypothermia patient rewarming on the arctic sun device. Nurse reported that the device sounded alarm 80 (non recoverable system error- the control processor failed to detect a simulated water temperature fault). This occurred once and nurse reported that the patient was rewarming too fast. Nurse already cycled the power and the alarm had not reoccurred. Nurse also stated that there were issues yesterday with the temperature in cable. The event log was checked and there was one alert 52 (extended period of cold water. The circulating water temperature has been below 10°c (50°f) for 8 of the previous 10 hours). Mss discussed causes of heat generation and nurse stated there was no more obvious signs of seizure activity, but the patient was warming too fast. Patient temperature was 35c, water temperature was11c and flow rate was 2. 4lpm. Rewarm rate read to rewarm from 34c at 0. 15c/hour to 36. 5c. Nurse had removed the bair hugger which was used for counter warming during the night. Mss explained about alert 52 and recommended the nurse to be diligent with skin checks and to peel the pads back very slowly. Mss explained about extended periods of cold-water delivery that might increase the risk for skin injury. Mss also explained that the water was staying cold because the patient was generating heat and recommended the nurse to discuss this with the care team. Mss advised to assess patient¿s skin underneath the arctic gel pads regularly and recommended to change out the device if alarm 80 reoccurred.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: TEMPERATURE CABLE
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13023433
• MDR Text Key: 285486091
• Report Number: 1018233-2021-08165
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/16/2021 Patient Sequence Number: 1