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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 Device Alarm System (1012); Break (1069); Decreased Pump Speed (1500); Pumping Problem (3016)
Patient Problem 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.
 
Event Description
It was reported that the nurse had received several alerts on the arctic sun device that return about every 30 minutes. The nurse had checked lines and connections. Event log showed an several alert 113( reduced water temp control). The patient temperature was 37. 5c, the target temperature was 35c, the water temperature was 24. 8c, the flow rate was 3. 4 l/m. The patient described as being very large and was using large size arctic gel pads and a universal pad. No visible shivering or microshivering. The patient trend indicator showed 2 bars going up. The arctic sun device was placed in manual mode at 10c. The nurse stated that the water temperature increased from 24. 8c to 28. 5c. The outlet monitor temperature (t1) was 26. 5c, the outlet control temperature (t2) was 26. 5c, the inlet temperature (t3) was 26. 4c, the chiller temperature (t4) was 3. 5c, the water flow rate was 3. 4 l/m, the inlet pressure was -7. 1 psi, the circulation pump command was 85%, the mixing pump command was 100%, the system hours was 2605. 1 and the pump hours was 2604. 1. Explained that the arctic sun device appeared to have a mixing pump failure and broken temp cable. Nurse would see if another arctic sun device available to swap out. This device was pulled from the ed. Sn dyasy010. The arctic sun device was not cooling due to a failed mixing pump and would be returned for warranty repair. Previous troubleshooting showed mixing pump issue. Per follow up via charge nurse on (b)(6) 2020, therapy was able to be completed on the loaner device.
 
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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 Key10495085
MDR Text Key206963818
Report Number1018233-2020-05716
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 03/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2021
Was Device Evaluated by Manufacturer? Yes
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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