MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Model Number 50000000E

Device Problem Computer Operating System Problem (2898)

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.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.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.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.

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.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.Per sample evaluation result received on 25may2022, 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.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14688676
• MDR Text Key: 300394346
• Report Number: 1018233-2022-04630
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other