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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 Problems Restricted Flow rate (1248); Defective Device (2588)
Patient Problems Alteration in Body Temperature (4568); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that there was low flow on the arctic sun device. The nurse stated they have been receiving alerts about leaks in the lines after sending patient to computed tomography. Nurse stated that they swapped out pads for a new set of pads, but they were still receiving alerts. Patient was at 34. 3c, target temperature was 33c, water temperature was 7. 6c, and there was no flow. Event log showed alert 001 and alert 002. Ms&s walked nurse through disconnecting and reconnecting using proper technique. All lines were straight with no kinks or bends noted. They started the therapy and device continued to flash priming and conditioning. There was no flow. The nurse placed device in manual mode at 5c. Temperature 1 was 6. 3c, temperature 2 was 6. 3c, temperature 3 was 27. 7c, temperature 4 was 5. 1c, water flow rate was 0, inlet pressure was 0, circulation pump command was 100, mixing pump command was 0, and heater was 0. System hours were 5612 and pump hours were 5112. The circulation pump appeared to have gone out. The nurse noted they have another device they could try.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10542339
MDR Text Key208148365
Report Number1018233-2020-05963
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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