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

Catalog Number 5000-01-01

Device Problems Short Fill (1575); Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Patient Involvement (2645); 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 arctic sun did not fill the pads.

Event Description

It was reported that the arctic sun did not fill the pads.

Manufacturer Narrative

The reported issue was confirmed by crs.The root cause of the reported issue was isolated to a faulty circulation pump.During calibration the unit displayed an error 80.The field technician could not complete the evaluation and the unit had to be returned to the crs depot.The unit was received at the crs depot on 02.27.19.Upon further evaluation it was noted the mixing pump was also bad, which would have caused the error 80.No repairs to date as there was a quotation discrepancy.This record will be closed until the cost of repair is decided upon and the unit is repaired.At that time the record will be reopened and updated accordingly.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: ¿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: ¿.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8422360
• MDR Text Key: 139043827
• Report Number: 1018233-2019-01304
• Device Sequence Number: 0
• Product Code: DWJ
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1