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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCITCSUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCITCSUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Insufficient Cooling (1130); Display or Visual Feedback Problem (1184); Defective Component (2292); Temperature Problem (3022)
Patient Problems Bradycardia (1751); Death (1802); Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. Device evaluated by mfr: the device was not returned.
 
Event Description
It was reported that a patient was insufficiently cooling while receiving therapy on the arctic sun device, sn# (b)(4), on (b)(6) 2019. The patient was placed on the arctic sun device following a code event while waiting for a procedure. The patient¿s temperature was 34. 8c while the target temperature was 33c. The water temperature was 30c and the flow rate was 2. 2l/min with a large set of pads and a universal pad. It was confirmed that there was an alert 113 (reduced water temperature control). The (b)(6) female patient was transferred to another icu floor in order to be put on a different arctic sun device. The patient was placed on arctic sun device sn# (b)(4), while arctic sun device sn# (b)(4) was sent to biomed for evaluation. The patient continued therapy on the second device and was in the rewarming phase when the family decided to put a dnr (do not resuscitate) in place and withdraw care. Before the arctic sun device was removed, the patient¿s heart rate decreased and the patient expired before care could be withdrawn. The cause of death was listed as natural causes on the death certificate. The nurse stated that cause of death was due to the patient¿s condition and was not device related. The patient had been admitted with a rash all over her body and several tests were performed to rule out possible diseases including measles. The patient was maxed out on vasopressors as well as receiving continuous renal replacement therapy.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCITCSUN 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 Key8579533
MDR Text Key145015968
Report Number1018233-2019-02326
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,Followup
Report Date 09/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2014
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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