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

Model Number 50000000E

Device Problem Insufficient Cooling (1130)

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

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.

Event Description

It was reported that nurse had a patient on the second arctic sun device trying to do normothermia (serial (b)(4) ). Both devices were giving alerts. Current device (serial (b)(4) ) in use was giving an alert 113 (reduced water temperature control). Patient temperature was 38. 7c, target temperature was 37. 8c and flow rate was 3. 1lpm. Event log showed alert 113 (reduced water temperature control), and system diagnostics showed that outlet monitor temperature (t1) was 31. 2c, outlet control temperature (t2) was 31. 1c, inlet temperature (t3) was 31. 2c, chiller temperature (t4) was 4. 2c, inlet pressure was -7. 0psi, circulation pump command was 85 percent, mixing pump command was 100 percent, system hours were 10525 and pump hours were 8374. Fluid fill line was originally connected to right drain port. Nurse placed the device in manual control mode at a target temperature of 5c. 15 minutes later, flow rate was 3. 3lpm, water temperature was still 31. 0c. Nurse discontinued that device and started normothermia therapy on the second device (serial (b)(4) ). Mss advised that alert 113 (reduced water temperature control) could mean the chiller or mixing pump on this device was bad also. Mss advised to send both devices to the biomed. Per follow up information received on 19jan2022, the first device refers to (serial (b)(4) ) and then switched to second device (b)(4). Per follow up information received on 21jan2022, nurse stated that both arctic sun devices were sent to biomed for repairs. Nurse stated that another arctic sun device was borrowed from another unit and therapy was completed with no further issues. There was no impact to the patient. Patient was male.

• 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: 13433950
• MDR Text Key: 286167189
• Report Number: 1018233-2022-00345
• 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
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 02/02/2022 Patient Sequence Number: 1