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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2022
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 emergency department (ed) had two arctic sun devices that were not working (serial (b)(4) ) and needed assistance. Nurse swapped out the current device (serial (b)(4) ) because patient was warming, and water temperature was decreasing. Target temperature was 38. 5c, patient temperature was 34. 6c, flow rate was 0. 0lpm and water temperature was 12. 8c. Patient arrived hypothermia and they were only rewarming. Mss walked through disconnecting and reconnecting the arctic gel pads using proper technique. All 4 arctic gel pads were connected. All lines were straight with no bends or kinks and device would not even prime. System diagnostics showed that outlet monitor temperature (t1) was 9. 1c, outlet control temperature (t2) was 9. 2c, inlet temperature (t3) was 21. 7c, chiller temperature (t4) was 5. 9c and water flow rate (wfr) was 0lpm, inlet pressure was -0. 1psi, circulation pump command was 100 percent, mixing pump command was 0 percent, heater command was 0 percent, system hours were 4459. 8 and pump hours were 4256. 2. Mss advised nurse that it appeared circulation pump had gone out on the device and sent top biomed for evaluation. Mss had the nurse turn on original device (serial (b)(4) ). Arctic gel pads were connected, and device immediately alerted to fill reservoir. Mss walked through adding water and adjusted settings for current patient. Ordering physician was in the room and approved rewarm from 34. 6c over 0. 5c/hour to target temperature of 38c. The device had flow rate of 2. 8lpm, water temperature was steadily increasing, and trend indicator (tdi) showed 2 bars trending upward. Nurse confirmed that they already had warm blankets on the patient and there was exposed abdomen. Mss advised to add a universal pad and explained that surface area was crucial in temperature management. It was noted that they likely saw an improvement in control with addition of a universal pad.
 
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 emergency department (ed) had two arctic sun devices that were not working (serial (b)(4) ) and needed assistance. Nurse swapped out the current device (serial (b)(4) ) because patient was warming, and water temperature was decreasing. Target temperature was 38. 5c, patient temperature was 34. 6c, flow rate was 0. 0lpm and water temperature was 12. 8c. Patient arrived hypothermia and they were only rewarming. Mss walked through disconnecting and reconnecting the arctic gel pads using proper technique. All 4 arctic gel pads were connected. All lines were straight with no bends or kinks and device would not even prime. System diagnostics showed that outlet monitor temperature (t1) was 9. 1c, outlet control temperature (t2) was 9. 2c, inlet temperature (t3) was 21. 7c, chiller temperature (t4) was 5. 9c and water flow rate (wfr) was 0lpm, inlet pressure was -0. 1psi, circulation pump command was 100 percent, mixing pump command was 0 percent, heater command was 0 percent, system hours were 4459. 8 and pump hours were 4256. 2. Mss advised nurse that it appeared circulation pump had gone out on the device and sent top biomed for evaluation. Mss had the nurse turn on original device (serial (b)(4) ). Arctic gel pads were connected, and device immediately alerted to fill reservoir. Mss walked through adding water and adjusted settings for current patient. Ordering physician was in the room and approved rewarm from 34. 6c over 0. 5c/hour to target temperature of 38c. The device had flow rate of 2. 8lpm, water temperature was steadily increasing, and trend indicator (tdi) showed 2 bars trending upward. Nurse confirmed that they already had warm blankets on the patient and there was exposed abdomen. Mss advised to add a universal pad and explained that surface area was crucial in temperature management. It was noted that they likely saw an improvement in control with addition of a universal pad.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC 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 Key13563793
MDR Text Key286245275
Report Number1018233-2022-00744
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 Other,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
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
Date Manufacturer Received01/28/2022
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: 02/18/2022 Patient Sequence Number: 1
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