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

Model Number 50000000

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

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 nurse was getting alert 05 (water reservoir empty) in the arctic sun device.And when nurse tried to fill the machine, it was not accepting water.Mss confirmed whether the tubes were disconnected from fluid delivery line, and they were disconnected.Nurse could hear the pump turning off and on.Nurse tried to restart machine and flow rate primed or stopped.Nurse stated system hours were 11807, pump hours were 11176, inlet pressure was -0.1psi, flow rate was 0 lpm, circulation pump command was 100 percent.Nurse stopped therapy, emptied, and disconnected pads and placed the device in manual control.There was no change in diagnostics.The device showed alert 41(low internal flow).It seemed like the circulation pump may need to be replaced.Per sample evaluation results received on 05-aug-2022, it was noted that the neutral connection between the main ac voltage circuit card and the power inlet module shows signs of electrical overstress.It was stated that both the evaporator outlet tube and the double bend tube to the manifold were found to be expanded beyond specification.It was also stated that the tank seals show signs of cracking and splitting.

Event Description

It was reported that the nurse was getting alert 05 (water reservoir empty) in the arctic sun device.And when nurse tried to fill the machine, it was not accepting water.Mss confirmed whether the tubes were disconnected from fluid delivery line, and they were disconnected.Nurse could hear the pump turning off and on.Nurse tried to restart machine and flow rate primed or stopped.Nurse stated system hours were 11807, pump hours were 11176, inlet pressure was -0.1psi, flow rate was 0 lpm, circulation pump command was 100 percent.Nurse stopped therapy, emptied, and disconnected pads and placed the device in manual control.There was no change in diagnostics.The device showed alert 41(low internal flow).It seemed like the circulation pump may need to be replaced.Per sample evaluation results received on 05-aug-2022, it was noted that the neutral connection between the main ac voltage circuit card and the power inlet module shows signs of electrical overstress.It was stated that both the evaporator outlet tube and the double bend tube to the manifold were found to be expanded beyond specification.It was also stated that the tank seals show signs of cracking and splitting.

Manufacturer Narrative

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

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15227646
• MDR Text Key: 305099370
• Report Number: 1018233-2022-06400
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• 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