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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Device Alarm System (1012); Inaccurate Flow Rate (1249); Short Fill (1575); Insufficient Flow or Under Infusion (2182)
Patient Problems Hypothermia (1915); No Consequences Or Impact To Patient (2199)
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 hypothermia therapy was initiated on the arctic sun device and after about 20 minutes, the flow rate stopped and the device received alert 01 (patient line open) and alert 02 (low flow). There was a large set of pads in place along with a universal. The patient's temperature was 36. 7c with a target of 33c. With the pads attached, the flow rate was 0l/min, inlet pressure was -0. 6psi, and the circulation pump was at 100%. Therapy was stopped, and the nurse attempted to empty the pads. The empty pads cycled would not complete, so the nurse disconnected the pads and enabled manual control with the water temperature set to 10c for 30 minutes. The device alarmed that the reservoir was empty, and troubleshooting could not be completed. The fill tube was missing, so the nurse was unable to fill the device. The nurse stated she would change out the device, and if the low flow continues, she would change out the pads. The pump hours on the device were noted at 2959 and the system hours were 3282. Per follow up with nurse (b)(6) via phone on 27aug2019, the device was swapped and therapy continued on the second device with no further issues. Per follow up with biomed via phone on 28aug2019, the device was filled and the fill tube replaced. The device was returned to service with no additional findings.
 
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Brand NameARCTICSUN 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 Key9075395
MDR Text Key185127782
Report Number1018233-2019-05691
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 09/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2014
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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