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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); Insufficient Flow or Under Infusion (2182); Gas Leak (2946)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
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 alerted for a low flow (alert 02) while the nurse attempted to start therapy. The patient had a medium arctic gel pad. They attempted disconnecting and reconnecting the arctic gel pads. It was confirmed that they were not holding near clamps and that connection clicks were heard. The patient temperature was 34. 7c and the target temperature was 33c. The arctic sun device displayed low air leak. It was then confirmed that the fluid delivery line was securely connected and had no bends, kinks or tears in any of the lines. The low air leak device did not return. The outlet monitor temperature (t1) was 5. 6c, the outlet control temperature (t2) was 5. 6c, the inlet pressure (t3) was 21. 6c, the chiller temperature (t4) was 5. 6c, the water flow rate was 0, inlet pressure (ip) was -0. 2 psi,the system hours were 4001. 2 and the pump hours were 3804. 9. The nurse guided on placing the device in manual control, the outlet monitor temperature (t1) was 10c, the outlet control temperature (t2) was 10c, the inlet pressure (t3) was 20. 6c , the chiller temperature (t4) was 10. 7c, the water flow rate was 1. 9 l/m, the inlet pressure (ip) was -4. 4 psi and the circulation pump command was 100%. It was noted that another arctic sun device was being brought up from the emergency department (ed). The nurse was the guided on how to drain the pads and starting therapy on new device. It was recommended the device be sent to biomed for evaluation. Sn (b)(4).
 
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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 Key11169981
MDR Text Key228215746
Report Number1018233-2021-00005
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
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 Received05/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2018
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: 01/14/2021 Patient Sequence Number: 1
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