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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 Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the arctic sun device was shutting down during use. The biomed powered it on and had allowed the device to run but the biomed could not see the device shutting down. The device would be sent in for investigation. Per follow up information received on 27-aug-2021, the biomed stated that they were unsure if the therapy was completed with the arctic sun device and was unsure of the exact issue. The arctic sun device was being sent to the depot for evaluation. As per the sample evaluation results received on 16-may-2022, low flow alarms during assessment testing occurred. Pressure readings were not steady and fluctuating between 0. 1psi and -11. 5psi while in manual normothermia mode using a test loop. This was caused by a failing circulation pump. The double bend tube from the tank to the manifold and the l tube from the chiller outlet to the chiller tank had expanded and deformed. The hot and neutral connections between the power inlet module and the main voltage circuit card showed signs of electrical overstress. Mixing pump motor had a cracked pump mounting thread. The tank seals were deformed and lifted from the tank. The patient temperature output (pto) was not functioning during acats (automated calibration and test system) calibration testing unit (ctu) testing.
 
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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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14573406
MDR Text Key293179770
Report Number1018233-2022-04320
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 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
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 Manufacturer09/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/16/2022
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: 06/02/2022 Patient Sequence Number: 1
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