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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 Overfill (2404); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Event Description
It was reported that a hypothermia patient was cooling to 33c on the arctic sun device.The nurse reported that the patient¿s temperature had dropped below the target temperature to 32.3c and the water was cold.The water temperature was 29c and flow rate was 3.3lpm.The reservoir level showed 5.Mss walked the nurse through draining 500 mls of water from the right drain port and enabled manual control and set the water temperature to 40c to test the heater.The water temperature rose to high 30s before disabling manual control and restarting the therapy.Also explained how overfill occurred and stated it was a frequent issue.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue was overfill.Also explained how overfill occurred and stated it was a frequent issue.The device did not meet specifications, and was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.Dhr is not required if the failure is not out-of-box.Based on the results of the investigation, no additional actions are needed.The instructions for use were found adequate and state the following: "1) fill the reservoir with sterile or distilled water only.2) four liters of water will be required to fill the reservoir at initial installation.3) add one vial of arctic sun temperature management system cleaning solution to the sterile or distilled water 4) from the patient therapy selection screen, press the either the normothermia or hypothermia button, under the new patient heading.5) from the hypothermia or normothermia therapy screen, press the fill reservoir button.6) the fill reservoir screen will appear.Follow the directions on screen." the device was not returned.
 
Event Description
It was reported that a hypothermia patient was cooling to 33c on the arctic sun device.The nurse reported that the patient¿s temperature had dropped below the target temperature to 32.3c and the water was cold.The water temperature was 29c and flow rate was 3.3lpm.The reservoir level showed 5.Mss walked the nurse through draining 500 mls of water from the right drain port and enabled manual control and set the water temperature to 40c to test the heater.The water temperature rose to high 30s before disabling manual control and restarting the therapy.Also explained how overfill occurred and stated it was a frequent issue.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13023311
MDR Text Key284307691
Report Number1018233-2021-08154
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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 Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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