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

Model Number 50000000L

Device Problems Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)

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. The device was not returned.

Event Description

It was reported that the arctic sun device was giving an alert 02 (low flow) when patient started hypothermia therapy. The flow rate was 0 l/min, the inlet pressure was -0. 4 psi. No bends, kinks or damage was noted to the tubings or fluid delivery line. Guided nurse through disconnecting and reconnecting arctic gel pads using the recommended technique and was listening for the audible click. System diagnostics showed the flow rate as 0 l/min and the inlet pressure as -0. 4 psi. Therapy was stopped and in the manual control, the flow rate was 0. 1 l/min, the inlet pressure was -1. 2 psi and the circulation pump was 100%. The fluid delivery line was removed from the arctic sun device. Nurse placed thumb over the left port and very slight suction noted. Recommended switching out the arctic sun device and informed that the circulation pump might need further troubleshooting. Recommended to label the arctic sun device as low flow and send to biomed. Nurse was unsure if another arctic sun device was available.

• 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: 10617582
• MDR Text Key: 209784630
• Report Number: 1018233-2020-06287
• 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: 03/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000L
• Device Catalogue Number: 50000000L
• 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: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse