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

Model Number 50000000E

Device Problems Inaccurate Flow Rate (1249); 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.

Event Description

It was reported that there was low flow on the arctic sun device. Therapy was initiated in the emergency room. They transported the patient up to the icu with the pads. The patient was being treated on arctic sun device , but they were getting low flow. They already changed a pad on the right side thinking it was the cause, but flow was still low. Flow rate was 0. 6lpm, inlet pressure was -2. 6psi, circulation pump (cp) was 100%, pump hours were 2434 and system hours were 2868. Ms&s suggested changing back to the emergency room device (dycry511) as flow was good on the initial device. Flow was 1. 5lpm, inlet pressure was -3. 5psi,circulation pump was 100%, pump hours were 1193 and system hours were 1044. Ms&s placed device in manual mode with only the fluid delivery line (fdl) attached. Flow rate was 1. 9lpm, inlet pressure was -6. 8psi, and circulation pump was 50%. They attached pads one at a time. The diagnostic was as follow: right chest (0. 8lpm, -7. 3psi, 31%cp), right thigh (1. 5lpm, -7. 2psi, 49%cp), left chest (1. 6lpm, -7. 1psi, 26%cp), left thigh (1. 4lsp, -4. 1psi, 100%cp). Ms&s asked to replace the left thigh pad with a universal pad or with the thigh pad from the set previously opened. Patient's temperature was originally 32c and was now up to 33c. Target was 35c, water was 40c and flow was 1lpm. Ms&s asked nurse to add a pad to the exposed abdomen, and to the left thigh if not already added.

• 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: 10556630
• MDR Text Key: 222089773
• Report Number: 1018233-2020-06079
• 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: 03/25/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/18/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse