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

Catalog Number UNKNOWN

Device Problems Insufficient Cooling (1130); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

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 patient was above target while undergoing therapy on arctic sun device. The patient temperature was 37. 8c, the target temperature was 35c, the water temperature was 31. 1c, and the flow rate was 2. 6lpm. They confirmed an alert 113 (reduced water temperature) in the event log. System hours were 7030, the pump hours were 6497, the chiller temperature (t4) was 4. 3c and the mixing pump command was 100%. Ms&s advised to stop therapy, empty pads and send device to biomed labeled mixing pump. Per follow up via nurse on 27jan2021, switched to a second device to continue therapy. Therapy was discontinued on second device. 2nd device was kept in service and 1st device was sent to biomed.

• Brand Name: UNKNOWN ARCTICSUN 5000
• Type of Device: UNKNOWN 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: 11345509
• MDR Text Key: 233078722
• Report Number: 1018233-2021-00651
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN
• 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: 08/19/2021
• 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: 02/18/2021 Patient Sequence Number: 1