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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 Improper or Incorrect Procedure or Method (2017); Overfill (2404); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the patient was not heating on the arctic sun device. The nurse reported the patient completed 24 hours of hypothermia on s/n (b)(4) and should now be rewarming to 37c at 0. 25c/hr. The patient's temperature stayed between 35c and 35. 5c. The control patient reads from 37c (in normothermia) at 0. 25c/hr. Patient's temperature was 35. 4c. Water's temperature was 22. 4c. Flow rate was 1. 9lpm. Heater command was 100%. Water level was 5. Pump hours were 588 and system hours 692. Ms&s had the nurse drain 500cc from the circulation tank and discussed how overfill can occur. The water was up to 34c by the end of the call. Flow rate was 2. 1lpm. Ms&s explained that flow above 1. 7lpm is acceptable and that the patient should now warm at 0. 25c/hr. Ms&s discussed how the water temperature adjusts automatically to attempt to keep patient at target and may always be warmer than the patient's temperature. Per follow up on 20jan2020 via phone, nurse (b)(6) stated she believed it was a nurse error. The 1st device was pulled out of the room and a 2nd device was used to complete therapy on the patient with no further issues. Per follow up on (b)(6) 2020 via phone, biomed (b)(6) stated she drained waster from the 1st device and kept it in service.
 
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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 Key9684982
MDR Text Key183917665
Report Number1018233-2020-00891
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2019
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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