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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 50000000
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2022
Event Type  malfunction  
Event Description
It was reported that hypothermia was initiated 2. 5 hours ago on the arctic sun device. Nurse reported that they have had flow issues since initiation of therapy. Device kept alarming. Nurse stated that patient temperature was 35. 8c, target temperature was 36c, water temperature was 23. 8c and flow rate was 0. Nurse attempted to check event log and they could not get any of the buttons to work. Mss asked the nurse to cycle the power and a red screen appeared. Nurse was unable to clear the alarm. Mss recommended the nurse to change different device and send this one to their biomedical engineering department for repair. Per follow up information received on 06-apr-2022, the device was being used on a patient during reported event, with no patient injuries. It was unknown if the patient completed therapy on this device, but was sent to biomed. The biomed will be sending the device in for 2k hour preventive maintenance. Per sample evaluation result received on 22-apr-2022, the arctic sun device would not fill and then short filled due to intermittent connector on the manifold harness. Device would not cool due to failed mixing pump. Per sample evaluation result received on 18-aug-2022, it was noted that the double bend tube was found to be expanded.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC 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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15321672
MDR Text Key301008165
Report Number1018233-2022-06792
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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
Type of Report Initial
Report Date 08/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
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 Manufacturer04/15/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/30/2022 Patient Sequence Number: 1
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