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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 Device Sensing Problem (2917); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
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 maintaining the target temperature during hypothermia therapy on the arctic sun device. The patient was experiencing myoclonic movements, and the nurse wanted to verify that the machine was responding appropriately before moving forward with addressing the heat generation. The target temperature was 33c. The patient temperature was reading as 33. 5c on the arctic sun device using a rectal probe and 33. 6c on the monitor using a foley probe. The water temperature was 25. 9c and flow rate was 3. 0 l/min. A large set of pads were in place with a universal on the abdomen. Trend indicator was trending up. Per troubleshooting with ms&s, t4 was 3c and the mixing pump command was reading between 0-18%. The nurse stated that the water temperatures had been ranging from 25-31c over the past few hours. The nurse was advised to adress heat generation per the facility's protocol. An hour later, the patient temperature peaked at 33. 8c. The water temperature went down to 11. 7c and the trend was neutral. The nurse was advised to be diligent with skin checks as the water temperature decreased. After half an hour, the patient temperature decreased to 33. 7c. The nurse stated that the patient was experiencing myoclonic jerking, and the md did not want to use a paralytic on the patient. The flow rate was noted at 2. 8l/min, and the trend indicator showed one arrow up. The nurse was advised to speak with md about addressing heat generation. Additional information was received via phone on 22mar2019 from nurse (b)(6) who stated that the patient was able to reach the target temperature and continue therapy with no furhter issues. He could not confirm if the patient completed therapy as he left at the end of his shift prior to completion of therapy.
 
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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 Key8505907
MDR Text Key142336409
Report Number1018233-2019-01907
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 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000L
Device Catalogue Number50000000L
Device Lot NumberN/A
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 Received04/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
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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