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

Model Number 50000000

Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182)

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. The device was not returned.

Event Description

It was reported that the arctic sun device was displaying low flow. The inlet pressure was -0. 1psi. The pads were disconnected and reconnected using proper technique. Therapy was initiated and the device primed and stopped. The pads were emptied and the device was placed back in manual control. The inlet pressure was -0. 1psi, the flow rate was 0l/min, the circulation pump was operating at 100%, and the device displayed alert 41 (low internal flow). The nurse was advised to send the device to the biomed. Per follow up on (b)(6) 2020, intensive care unit nurse stated the device was sent to biomed. It was unknown if therapy was completed on the device.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10138850
• MDR Text Key: 195217787
• Report Number: 1018233-2020-03720
• Device Sequence Number: 1
• Product Code: DWJ
• 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse