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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
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 booting up to a red screen stating, that the device failed to start. Mss discussed that this was indicative of a loss of communication with the control panel. Biomed stated that they already replaced the isolation card and stated would rather try replacing other components from an arctic sun device and then would attempt to troubleshoot. Mss discussed the pathways and possible components with them. Biomed called back and stated that they would like to send the device in for repair. As per email response received on 06dec2021, biomed stated that there was no patient involvement, and the arctic sun device would be sent to the depot for repairs. As per sample evaluation result received on (b)(6) 2022, it was reported that the device booted up to a red screen. This was a combination of failed processor, power supply, and input output circuit cards in the card cage. Mss stated that the flow was reading zero with the circulation pump at 100 percent. The flowmeter impeller was bound tight and would not spin. Actual flow was confirmed through a shunt line although measured with a test flowmeter 1 lpm too low. Bypass flow was measured low as well. This was due to a failing circulation pump. The device will not heat due to a failed card cage power supply not providing heater relay voltage to the main ac power supply card. The device overfilled during decontamination. There was a lot of debris seen in the tank and in the level sensor fill tube that could have stopped water from entering the tube and into the fill sensor. Once cleared the device filled properly. It had an alarm 61 (non-recoverable system error) caused by faulty processor.
 
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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 Key14688677
MDR Text Key300394462
Report Number1018233-2022-04629
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2022
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: 06/14/2022 Patient Sequence Number: 1
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