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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 50000000L
Device Problem Inaccurate Flow Rate (1249)
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 received an alert 02 (low flow) when the user tried to start the therapy on the device with serial number ((b)(4)) 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 the arctic sun device. The user ordered a new arctic sun device and the nurse checked the fluid delivery line for any damage and  no damage were observed. The arctic sun device turned on and placed in a manual control. The system hours were 4679, pump hours were 4167, inlet pressure was -7. 1psi, the flow rate was 1. 7 lpm and the circulation pump command was 64%. Ms&s explained the arctic sun device appeared to be in the specification and the nurse went to the new room to see whether 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 from the back of the device. It appeared damaged and was unable to plug the temperature cable back into the arctic sun device. Ms&s explained how the connection was sheathed, but the nurse was still unable to get it back in. Also stated that the nurse would send the device to biomed labeled with temperature in cable needed and low flow rate.
 
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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 Key11387894
MDR Text Key233897478
Report Number1018233-2021-00851
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080159
UDI-Public(01)00801741080159
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 09/27/2021
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
Device Model Number50000000L
Device Catalogue Number50000000L
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 Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2016
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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