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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 50000000L
Device Problems Restricted Flow rate (1248); Failure to Prime (1492); Insufficient Flow or Under Infusion (2182)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 would not primed and displayed low flow alert with the flow rate as zero. The nurse disconnected and reconnected the arctic gel pads and restarted that arctic sun device but the flow rate was a zero. Nurse checked the troubleshooting section which was mentioned to drained off 1000mls of water. The nurse drained 900mls of water then the arctic sun device displayed the alert that the arctic sun device was empty however, the device would not take water. The patient was using 2 large artic gel pad on chest, one arctic gel pad on leg and one universal arctic gel pad on the one leg due to a wound which was not associated with the arctic sun device. Esophageal probe was in place to arctic sun device. Event log showed multiple alarm 05 (water reservoir empty) and alert 07 (empty pads not complete) with the arctic gel pad connected. Had disconnected the arctic gel pad and attempted to fill but the arctic sun device still would not take water. Checked that the fill tube was in the correct position. Advised to get another device. Walked through setting up s/n (b)(4) and starting therapy then the flow rate was settled at 3. 1l/min, water temperature was 25. 5c and patient temperature was at 33c with the target temperature of 33c. Recommended to label the arctic sun device with a note of zero flow and would not fill. Per follow up via charge nurse on 24jul2020 , patient completed therapy using another device. Original device sent to biomed.
 
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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 Key10380384
MDR Text Key205507157
Report Number1018233-2020-05054
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 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000L
Device Catalogue Number50000000L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2019
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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