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

Model Number 50000000

Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182)

Patient Problems Alteration in Body Temperature (4568); 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 was getting 113 (reduced water temperature control) alerts and was not cooling. Per additional information received from the mss on 10sep2020 while assisting bedside nurse rose, the arctic sun device was not cooling. Received an alert low flow which was resolved earlier. The patient temperature was 37c, the target temperature was 33c, the water temperature was 32. 9c, the flow rate was 2. 4 l/m. The patient was 66 kg 5'10" with full arctic gel pad coverage noted with no exposed abdomen. While talking, the arctic sun device gave an alert 113 (reduced water temperature control). Walked through placing the arctic sun device in manual mode at 10c, then the outlet monitor temperature (t1) was 32. 9c, the outlet control temperature (t2) was 32. 8c, the inlet temperature (t3) was 32. 8c, the chiller temperature (t4) was 3. 6c, the water temperature was 2. 5 l/m , the inlet pressure was -7, the circulation pump command was 67% an the mixing pump command was 100%. Nurse confirmed that there was another arctic sun device available and could swap to for continuation of therapy. Sending this arctic sun device (b)(4) to biomed. Would call back for assistance with starting therapy on new arctic sun device. Nurse called back and walked nurser through emptying arctic gel pads and starting therapy on (b)(4). Confirmed they would start as they would a new patient as the patient has not reached target get. The patient temperature was 37. 1c and the flow rate was 2. 9lpm. The water temperature was decreasing at 23c by the end of the call. Called back 30 minutes later. The water temperature was dropping, but the patient's temperature was not responding yet. The nurse would address the heat generation and call back if needed.

• 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: 10623091
• MDR Text Key: 221770702
• Report Number: 1018233-2020-06319
• 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: 03/31/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/02/2020
• 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: 09/24/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse