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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE ARCTIC SUN TEMPERATURE CABLE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE ARCTIC SUN TEMPERATURE CABLE Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
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 gave alert 02 (low flow) when user tried to start therapy on dyauy014 and also they did all the proper troubleshooting on the device. The nurse ended up replacing the arctic gel pads, but they were still getting low flow on this arctic sun device. The user ordered a new arctic sun device and had nurse to check fluid delivery line for any damage and noted none. The arctic sun device turned on and placed in manual control. The system hours were 4679, pump hours were 4167, inlet pressure was -7. 1psi, flow rate was 1. 7lpm and circulation pump command was 64%. Explained the arctic sun device appeared to be in specification and nurse took to the new room to see if the other arctic sun device had arrived, but it was already on the patient. As they were moving the arctic sun device, the user had accidentally stepped on the temperature in cable/probe and pulled it from the back of the device. It appeared damaged and was unable to plug temperature in cable back into arctic sun device. Explained how connection was sheathed but the nurse was still unable to get it back in. Also stated that the nurse would send to biomed labeled "temperature in cable needed and low flow rate. ".
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of DeviceARCTIC SUN TEMPERATURE CABLE
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 Key11387866
MDR Text Key243357806
Report Number1018233-2021-00853
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
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received10/04/2021
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: 02/26/2021 Patient Sequence Number: 1
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