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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE TEMP IN CABLE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE TEMP IN CABLE Back to Search Results
Catalog Number 735-02
Device Problems Erratic or Intermittent Display (1182); Temperature Problem (3022)
Patient Problems Cardiac Arrest (1762); Death (1802); No Consequences Or Impact To Patient (2199)
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 arctic sun device would not suction sterile water into the reservoir upon device set-up. During a call with ms&s, it was determined by troubleshooting that the fluid delivery line was not working properly. The fluid delivery line was replaced, and therapy was initiated on an (b)(6) year old male patient status post cardiac arrest. During a follow-up phone call on 09may2019 with the charge nurse, it was reported that the patient had received therapy for three and a half days and reached the target temperature. The nurse also reported that the temperature probe cable had been giving erratic temperatures, but they were able to use the cable to complete therapy. After 14 hours in the maintenance phase, the family decided to withdraw care and the patient expired. The charge nurse stated that the cause of death was due to the patient's condition and was not device related. The charge nurse stated the cause of death was cardiorespiratory arrest. The patient had been receiving vasopressors and had a significant cardiac history.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of DeviceTEMP IN CABLE
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 Key8656001
MDR Text Key149788588
Report Number1018233-2019-02841
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 07/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number735-02
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 Received06/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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