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

Catalog Number 5000-01-03

Device Problem Disconnection (1171)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that the during the six monthly service arctic sun device was failed when ran manual control cooling function.Only went from 37 degrees down to 27 degrees in 30 minutes.Target temperature was 4 degrees.They went through system diagnostics and chiller temperature ranged between 27-33 degrees.It needs to be under 10 degrees.In evaluation findings they confirmed that the arctic sun device was visually inspected and no issues were observed.Incoming system hours was 493, pump hours was 431.They confirmed the device was not cooling.Chiller temperature (t4) does not drop in value.The root cause of the not cooling was determined to be a failed chiller.The root cause of the alarm 41 (low internal flow) and zero flow reading was determined to be a failed flowmeter.The flowmeter plugged in backwards had no bearing on the reading.The decon tech noted the circulation pump unplugged and plugged it back in.The flowmeter connector was plugged in backwards on the i/o card.Alarm 41 during decon and assessment for low internal flow of 0 lpm.No service records were found related to the reported problem.Other observation were the screen is not responsive.Physical damage(dents) were observed on several locations on the screen.The brass metal tubing around compressor is freezing.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 18446220
• MDR Text Key: 331936473
• Report Number: 1018233-2023-09482
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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