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

Model Number 50000000L

Device Problems Overfill (2404); Device Sensing Problem (2917)

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

Event Date 02/10/2021

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 an arctic sun device was getting alert 113 (reduced water temperature control) and the patient was in rewarming phase. Water temperature was 30. 6 c, patient temperature was via esophageal probe 33. 8 c, via rectal probe connected to device 34. 8 c. There was a good flow, water level had 4 bars. Rewarm from reading was 33. 6 c, rate 0. 25 c/hr and target temperature was 37 c. Ms&s decided to check heater in case it was an overfill scenario. They rained 400 cc off right drain port and set device to 42 c in manual mode. Water temperature was at 41 c range. The user put device back into rewarming. Ms&s explained temperature lag time difference with esophageal probe versus rectal probe and caused for alert 113. Ms&s recommended checking alternate source for temperature to see which correlates more closely and also explained that if the user gets alert 113 again to take device out of service.

• 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: 11435932
• MDR Text Key: 238366224
• Report Number: 1018233-2021-01078
• 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: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000L
• Device Catalogue Number: 50000000L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 03/08/2021 Patient Sequence Number: 1