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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 Problem Insufficient Heating (1287)
Patient Problems Death (1802); Respiratory Distress (2045)
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 a patient was insufficiently heating while receiving therapy on an arctic sun device. The patient¿s temperature was 33. 8c and the target was 37c. The water temperature was 39. 8c and the flow rate was 2. 1l/min. The rewarm tab read from 34. 8c, at a rate of 0. 50c/hour to 37c. Per troubleshooting with ms&s, the nurse added a universal pad and warm blankets. The nurse also turned on the vent warmer and increased the room temperature. A few hours passed and the patient still did not meet the rewarm target. The patient¿s temperature was then 34. 4c and the water temperature was 42c. During a follow up call on (b)(6) 2019, the assistant nurse manager, (b)(6), stated the patient was admitted to the icu for respiratory distress and was also receiving continuous renal replacement therapy (crrt). The patient completed therapy on (b)(6) 2019 and was later placed on comfort care measures. Nurse (b)(6) stated the patient expire on (b)(6) 2019 and the cause of death was due to anoxic brain injury related to respiratory distress and was not device related.
 
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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 Key9290448
MDR Text Key179430476
Report Number1018233-2019-07113
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 12/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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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