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

Model Number 50000000E

Device Problems Insufficient Heating (1287); Use of Device Problem (1670); Overfill (2404)

Patient Problem 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 biomed received an arctic sun device with a note on it stating that the device would not heat the water. The reservoir level was showing five bars, and there were multiple alert 113s (reduced water temperature control) in the event log. Per troubleshooting with ms&s, the biomed was walked through draining and refilling the device with the same water. The device was over filled by 500ml. Manual control was enabled with the water temperature set to 40c for 30 minutes. T1 and t2 were 19. 1c but quickly rose to 37c. T4 was 5. 8c. With only the fluid delivery line attached, the flow rate was 1. 6l/min, the inlet pressure was -7psi, and the circulation pump command was 54%. The pump hours were noted at 4676 and system hours noted at 4869. Manual control was disabled.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCITC 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: 8773061
• MDR Text Key: 150592348
• Report Number: 1018233-2019-03746
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/09/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse