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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 Problems Overfill (2404); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2022
Event Type  malfunction  
Event Description
It was reported that the arctic sun device device was displaying alert 113 (reduced water temperature control) and that patient temperature and water temperature had not changed in hours. Mss confirmed using device in normothermia mode. Nurse stated that the target temperature was 37. 0c, patient temperature was 37. 1c, water temperature was 32. 0c, flow rate was 2. 3lpm, water reservoir level was full, trend indicator was thermoneutral. Nurse stated that the system diagnostics showed system hours were 20518. 6, pump hours were 16666. 8, outlet monitor temperature (t1) was 32. 4c, outlet control temperature (t2) was 32. 4c, inlet temperature (t3) was 32. 5c and chiller temperature (t4) was 4. 2c. Mss asked the nurse to drain 500ml from right drain port. After draining therapy resumed with flow rate of 2. 8lpm, no alerts during remainder of call. Mss stated that the device had been overfilled but it had high system and pump hours and could have a bad mixing pump. Mss advised to send the device to biomed if they had same alerts again.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
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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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14487625
MDR Text Key292504132
Report Number1018233-2022-04031
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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
Type of Report Initial,Followup
Report Date 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2022
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 Received08/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
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: 05/24/2022 Patient Sequence Number: 1
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