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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 50000000E
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2022
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 nurse had a patient on the second arctic sun device trying to do normothermia (serial (b)(4) ). Both devices were giving alerts. Current device (serial (b)(4) ) in use was giving an alert 113 (reduced water temperature control). Patient temperature was 38. 7c, target temperature was 37. 8c and flow rate was 3. 1lpm. Event log showed alert 113 (reduced water temperature control), and system diagnostics showed that outlet monitor temperature (t1) was 31. 2c, outlet control temperature (t2) was 31. 1c, inlet temperature (t3) was 31. 2c, chiller temperature (t4) was 4. 2c, inlet pressure was -7. 0psi, circulation pump command was 85 percent, mixing pump command was 100 percent, system hours were 10525 and pump hours were 8374. Fluid fill line was originally connected to right drain port. Nurse placed the device in manual control mode at a target temperature of 5c. 15 minutes later, flow rate was 3. 3lpm, water temperature was still 31. 0c. Nurse discontinued that device and started normothermia therapy on the second device (serial (b)(4) ). Mss advised that alert 113 (reduced water temperature control) could mean the chiller or mixing pump on this device was bad also. Mss advised to send both devices to the biomed. Per follow up information received on 19jan2022, the first device refers to (serial (b)(4) ) and then switched to second device (b)(4). Per follow up information received on 21jan2022, nurse stated that both arctic sun devices were sent to biomed for repairs. Nurse stated that another arctic sun device was borrowed from another unit and therapy was completed with no further issues. There was no impact to the patient. Patient was male.
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Brand NameARCTIC SUN® 5000
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
MDR Report Key13433950
MDR Text Key286167189
Report Number1018233-2022-00345
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
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: 02/02/2022 Patient Sequence Number: 1