• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182)
Patient Problems Alteration in Body Temperature (4568); 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 arctic sun device was getting 113 (reduced water temperature control) alerts and was not cooling. Per additional information received from the mss on 10sep2020 while assisting bedside nurse rose, the arctic sun device was not cooling. Received an alert low flow which was resolved earlier. The patient temperature was 37c, the target temperature was 33c, the water temperature was 32. 9c, the flow rate was 2. 4 l/m. The patient was 66 kg 5'10" with full arctic gel pad coverage noted with no exposed abdomen. While talking, the arctic sun device gave an alert 113 (reduced water temperature control). Walked through placing the arctic sun device in manual mode at 10c, then the outlet monitor temperature (t1) was 32. 9c, the outlet control temperature (t2) was 32. 8c, the inlet temperature (t3) was 32. 8c, the chiller temperature (t4) was 3. 6c, the water temperature was 2. 5 l/m , the inlet pressure was -7, the circulation pump command was 67% an the mixing pump command was 100%. Nurse confirmed that there was another arctic sun device available and could swap to for continuation of therapy. Sending this arctic sun device (b)(4) to biomed. Would call back for assistance with starting therapy on new arctic sun device. Nurse called back and walked nurser through emptying arctic gel pads and starting therapy on (b)(4). Confirmed they would start as they would a new patient as the patient has not reached target get. The patient temperature was 37. 1c and the flow rate was 2. 9lpm. The water temperature was decreasing at 23c by the end of the call. Called back 30 minutes later. The water temperature was dropping, but the patient's temperature was not responding yet. The nurse would address the heat generation and call back if needed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN 5000
Type of DeviceARCTIC 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 Key10623091
MDR Text Key221770702
Report Number1018233-2020-06319
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
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 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-