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

Model Number 50000000E

Device Problems Device Alarm System (1012); Break (1069); Decreased Pump Speed (1500); Pumping Problem (3016)

Patient Problem 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 nurse had received several alerts on the arctic sun device that return about every 30 minutes. The nurse had checked lines and connections. Event log showed an several alert 113( reduced water temp control). The patient temperature was 37. 5c, the target temperature was 35c, the water temperature was 24. 8c, the flow rate was 3. 4 l/m. The patient described as being very large and was using large size arctic gel pads and a universal pad. No visible shivering or microshivering. The patient trend indicator showed 2 bars going up. The arctic sun device was placed in manual mode at 10c. The nurse stated that the water temperature increased from 24. 8c to 28. 5c. The outlet monitor temperature (t1) was 26. 5c, the outlet control temperature (t2) was 26. 5c, the inlet temperature (t3) was 26. 4c, the chiller temperature (t4) was 3. 5c, the water flow rate was 3. 4 l/m, the inlet pressure was -7. 1 psi, the circulation pump command was 85%, the mixing pump command was 100%, the system hours was 2605. 1 and the pump hours was 2604. 1. Explained that the arctic sun device appeared to have a mixing pump failure and broken temp cable. Nurse would see if another arctic sun device available to swap out. This device was pulled from the ed. Sn dyasy010. The arctic sun device was not cooling due to a failed mixing pump and would be returned for warranty repair. Previous troubleshooting showed mixing pump issue. Per follow up via charge nurse on (b)(6) 2020, therapy was able to be completed on the loaner device.

• 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: 10495085
• MDR Text Key: 206963818
• Report Number: 1018233-2020-05716
• 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: 03/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/04/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse