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

Model Number 50000000

Device Problems Device Alarm System (1012); Inaccurate Flow Rate (1249); Short Fill (1575); Insufficient Flow or Under Infusion (2182)

Patient Problems Hypothermia (1915); No Consequences Or Impact To Patient (2199)

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 hypothermia therapy was initiated on the arctic sun device and after about 20 minutes, the flow rate stopped and the device received alert 01 (patient line open) and alert 02 (low flow). There was a large set of pads in place along with a universal. The patient's temperature was 36. 7c with a target of 33c. With the pads attached, the flow rate was 0l/min, inlet pressure was -0. 6psi, and the circulation pump was at 100%. Therapy was stopped, and the nurse attempted to empty the pads. The empty pads cycled would not complete, so the nurse disconnected the pads and enabled manual control with the water temperature set to 10c for 30 minutes. The device alarmed that the reservoir was empty, and troubleshooting could not be completed. The fill tube was missing, so the nurse was unable to fill the device. The nurse stated she would change out the device, and if the low flow continues, she would change out the pads. The pump hours on the device were noted at 2959 and the system hours were 3282. Per follow up with nurse (b)(6) via phone on 27aug2019, the device was swapped and therapy continued on the second device with no further issues. Per follow up with biomed via phone on 28aug2019, the device was filled and the fill tube replaced. The device was returned to service with no additional findings.

• Brand Name: ARCTICSUN 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: 9075395
• MDR Text Key: 185127782
• Report Number: 1018233-2019-05691
• 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

• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/17/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse