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

Model Number 50000000E

Device Problem Nonstandard Device (1420)

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

Event Date 09/16/2022

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 biomed stated the arctic sun device was due for 2000 hours preventive maintenance and a previous work order showed it was recommended last year due to a bad mixing pump.Biomed stated that the touch screen also froze from time to time and wanted to check it out to see if a software reloading corrected the issue.Per follow up information received on 29-jul-2022, there was no patient involvement reported.A quote has been sent to customer and they will determine if they send device in for service.Per sample evaluation results received on (b)(6) 2022, it was reported that the one of the four nut plates in the outer shell used to secure the control panel bracket to the shell was found to be stripped out and spinning in the shell freely.It was noted that other repairs completed included replacement of the double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.It was also noted that the replacement of the tank seals due to lifting from the tank, tearing, and glue deteriorating.

Manufacturer Narrative

Upon further review, bd has determined that this mdr event is not reportable.The actual/suspected device was inspected.

Event Description

It was reported that biomed stated the arctic sun device was due for 2000 hours preventive maintenance and a previous work order showed it was recommended last year due to a bad mixing pump.Biomed stated that the touch screen also froze from time to time and wanted to check it out to see if a software reloading corrected the issue.As per follow up information received on 29jul2022, there was no patient involvement reported.A quote has been sent to customer and they will determine if they send device in for service.As per sample evaluation results received on 16sep2022, it was reported that the one of the four nut plates in the outer shell used to secure the control panel bracket to the shell was found to be stripped out and spinning in the shell freely.It was noted that other repairs completed included replacement of the double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.It was also noted that the replacement of the tank seals due to lifting from the tank, tearing, and glue deteriorating.

• 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: 15494108
• MDR Text Key: 300709720
• Report Number: 1018233-2022-07475
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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