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

Model Number 50000000

Device Problems Display or Visual Feedback Problem (1184); Failure to Pump (1502); Temperature Problem (3022)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

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 the second arctic sun device with sn (b)(4) was having an alert 113 ( reduced water temperature control) and was not cooling the water. The target temperature was 37c, the patient temperature was 36. 9c, the water temperature was 29c and the flow rate was 2. 9lpm. Checked the system diagnostics, the chiller temperature (t4) was 3. 2c, the mixing pump command was 100%. Asked the nurse to change back to the original arctic sun device sn (b)(4) which was not displaying the patient temperature initially. After the changing the temperature cable, the patient temperature displayed. The water temperature decreased in the sn (b)(4) along with the faulty temperature cable was sent to the biomed.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10569630
• MDR Text Key: 208559807
• Report Number: 1018233-2020-06130
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/22/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse