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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 Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
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 mss worked with biomed. A functional check showed the flow in bypass was 1. 7 lpm, the circulation pump command was 49 percentage and inlet pressure were -7psi and explained that the arctic sun device was working correctly and it's possible that the flow observed was due to an incorrect set up or a damaged pad being connected. Biomed would return the device to service. Therapy was started on the arctic sun device was giving an alert 01 (patient line open) and alert 02 (low flow). But there was no flow at all, and patient temperature was 40. 2c, target temperature was 38c, water temperature was 6. 9c. The user disconnected and reconnected using proper technique, then the user restarted therapy but there was no flow again. Device stayed on priming and then alerted no flow. So, the user placed the device in manual control at 4c. Outlet monitor temperature (t1) was 6. 9c, outlet control temperature (t2) was 7c, inlet temperature (t3) was 26. 7c (verified twice), chiller temperature (t4) was 4. 2c, water flow rate (wfr) was 0. 0 l/m, inlet pressure (ip) was 0 psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 19 percentage, water return line (wrl) was 4, system hours were 2647. 3 and pump hours was 2082. 1. Then the device alerted 41 (low internal flow). Mss advised nurse to swap out device and send this one to biomed for evaluation. Per sample evaluation, the hot and neutral side connector from main power inlet module to ac cca showed signs of electrical overstress. The double bend tube had expanded.
 
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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 Key12352121
MDR Text Key267619998
Report Number1018233-2021-05070
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
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? No
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: 08/22/2021 Patient Sequence Number: 1
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