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

Catalog Number 5000-01-01

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 system alert 113 occurred.The patient was switched to a second device to complete therapy.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to a device maintenance issue as there was a lot of dust in the condenser.The condenser of the chiller unit was cleaned, a functional test was performed, and the unit passed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: " a dirty chiller condenser will significantly reduce the cooling capacity of the control module.¿ to clean the condenser, wipe the dust from the exterior grill using a soft cloth.Depending on the quality of your institution¿s air, periodically remove the back cover and vacuum or brush the condenser fins.At a minimum the condenser fins should be cleaned annually.Maintenance activities should be performed by qualified personnel.".

Event Description

It was reported that an alert 113 occurred.The patient was switched to a second device to complete therapy.

• Brand Name: ARCTICSUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9224173
• MDR Text Key: 179414799
• Report Number: 1018233-2019-06682
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1