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 arctic sun device had an alert 113 (reduced water temperature control). The target temperature was 37c, the patient temperature was 39c, the water temperature was 29c, the flow rate was 2. 9 l/min. There was an adequate arctic gel pad coverage. The patient has been on therapy for approximately 3 hours. System diagnostic showed that the outlet monitor temperature (t1) was 29. 2c, the outlet control temperature (t2) was 29. 2c, the chiller temperature (t4) was 4. 6c, the flow rate was 3l/min, the circulation pump command was 80%, the mixing pump command was 100%, the system hours were 5370. 3 and the pump hours were 4514. 9. Informed that the mixing pump might need further troubleshooting and recommended changing out the arctic sun device. Nurse stated that they had a second device and was able to switch it out. The nurse would call back if needed. Advised to label this arctic sun device as alert 113 (reduced water temperature control) and send to biomed for further troubleshooting.

• 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: 10600626
• MDR Text Key: 214152173
• Report Number: 1018233-2020-06247
• 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: 03/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/29/2020
• 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: 09/17/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse