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

Model Number 50000000

Device Problems Circuit Failure (1089); Overheating of Device (1437)

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

Event Date 07/27/2021

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 not cooling and it was confirmed during the functional check that the root cause of the reported issue isolated to a faulty mixing pump.A test mixing pump was installed to cool and the mixing pump was serviced during the preventive maintenance process.It was also reported that the device was primed to fill and the coin cell was replaced due to age.The circuit card assembly (cca) board wire terminal showed signs of electrical stress and the shell had a stripped pem.During the preventive maintenance process the circulation pump was serviced and the circuit card assembly (cca) circuit card heater both the drain valves manifold o rings the shell and the coin cell battery were replaced.The arctic sun 5000 passed all the performance tests calibration and the electrical safety tests.The device was functioning properly and ready for use.

Manufacturer Narrative

The reported issue was confirmed, manufacturing related.The root cause of the reported issue was covered under capa 1405844.The device was evaluated upon receipt and the signs of electrical stress were noted.The cca card was replaced.The arctic sun 5000 passed all performance testing, calibration, electrical safety tests and is functioning properly.Unit is ready for use.The overheating of the wires was assessed by the investigation tasks and used to complete the root cause evaluation using the fishbone methodology (refer to ac cca power inlet module powerpoint for fishbone diagram).It was concluded that the following was the root cause: supplier ¿ root cause o inadequate verification and validation activities of the crimping process o single pull test did not provide stability of process o evidence was not provided when requested for maintenance of records or crimp tools o no crimp cross-sections provided the actual/suspected device was evaluated.

Event Description

It was reported that the arctic sun device was not cooling and it was confirmed during the functional check that the root cause of the reported issue isolated to a faulty mixing pump.A test mixing pump was installed to cool and the mixing pump was serviced during the preventive maintenance process.It was also reported that the device was primed to fill and the coin cell was replaced due to age.The circuit card assembly (cca) board wire terminal showed signs of electrical stress and the shell had a stripped pem.During the preventive maintenance process the circulation pump was serviced and the circuit card assembly (cca) circuit card heater both the drain valves manifold o rings the shell and the coin cell battery were replaced.The arctic sun 5000 passed all the performance tests calibration and the electrical safety tests.The device was functioning properly and ready for use.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12346445
• MDR Text Key: 267420162
• Report Number: 1018233-2021-05045
• 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): Y
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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