MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN 5000; SYSTEM, THERMAL REGULATING

Model Number 50000000E

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Protective Measures Problem (3015); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2021

Event Type  malfunction  

Event Description

Cooling device failed.Per report, when it was placed, an error message appeared - e113.This is a water temperature notification that it is not being temperature controlled.The device was pulled out of service and tested by biomedical department.They noted another error message -e80.This means the control processor failed to detect a simulated water temperature fault.Biomed contacted the vendor who reported the mixing pump was not working correctly.It was not pushing enough cold water into the lines to cool the patient to the correct temperature.The vendor noted the pump needed to be replaced.The unit was sent to the vendor for repair.Biomed also had another unit with the same issue and it too was sent for repair.Biomed reported the units had appropriate preventative maintenance.Manufacturer has not responded to date for either unit.

• Brand Name: ARCTIC SUN 5000
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue suite 200; louisville CO 80027
• MDR Report Key: 11214170
• MDR Text Key: 228170154
• Report Number: 11214170
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

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 Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Weight: 115