• 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 Device Alarm System (1012); Insufficient Cooling (1130); No Flow (2991)
Patient Problems Death (1802); No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
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 on 07aug2020, that the arctic sun device, sn (b)(4), was displaying an alert 01 (patient line open) and there was no flow on the device. Therapy had been ongoing for one hour. The nurse phoned ms&s for troubleshooting assistance. Ms&s advised the nurse on draining the gel pads, disconnecting and reconnecting, and verifying a secure connection of the fluid delivery line on the back of the device. The nurse noted there was dust on the back of the device. Ms&s advised clearing the dust and ensuring the device was not placed against the wall. All lines were straight with no bends or kinks and therapy was restarted. 19. 7c; 19. 6c; 18. 3c; 5c; flow rate 2. 9 l/m; inlet pressure -7. 4 psi; circulation pump command 0%; heater command 28%; water rate level 5; system hours 1614. 3; pump hours 1447. 7. The flow rate leveled out at 2. 6 l/m. The nurse was advised to call back if any additional issues arose. The nurse phoned ms&s two hours later and reported the device was not cooling the patient. The target temperature was 33c. The patient¿s temperature was 34. 7c via an esophageal probe and 37. 7c via a rectal temperature probe. Flow rate was at 2. 8l/m, water temperature 34. 7c and the trend indicator was thermoneutral. Ms&s discussed temperature discrepancies between the two probes and encouraged managing therapy with the esophageal probe. Ms&s had the nurse place the device in manual mode at 10c. Over approximately twenty minutes, the device water temperature dropped: was 15c; 15. 1c; 18c; 13c; flow rate 2. 7 l/m; inlet pressure was -7. 0 psi; circulation pump command 71%; mixing pump command was 100%. Ms&s advised the nurse on how to remove the device from manual mode. The nurse was advised that if the patient¿s temperature did not increase and the water temperature of the device increased, the device would need to be swapped. It was also advised that routine maintenance may assist if the device is dirty and potentially blocking airflow to the chiller, prohibiting efficient cooling. Ms&s placed a follow-up phone call to the nurse an hour later and there was no response. A voicemail message was left. During a follow-up phone call on 17aug2020 by an fa specialist, the nurse advised that the device had been swapped out and that there were no further therapy issues. The nurse reported the patient expired and referred the fa specialist to the charge nurse. The charge nurse stated therapy had been discontinued at the request of the patient¿s family. Additional information was received on 18aug2020 during a clinical follow-up phone call with the icu charge nurse. The patient was a (b)(6) year-old-male who was admitted to the facility status post cardiac arrest. The patient was found in his yard unresponsive and experienced two ventricular fibrillation cardiac arrests with cardiopulmonary resuscitation. The patient had a history of hypertension and back pain. Patient was admitted to the facility on (b)(6) 2020. All medical care was withdrawn on (b)(6) 2020 and patient was placed on comfort care measures only. The patient expired on 08aug2020. The nurse stated the death was due to his condition and not related to the device.
 
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 Key10469662
MDR Text Key206175365
Report Number1018233-2020-05569
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 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-