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

Device Problems Insufficient Flow or Under Infusion (2182); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  malfunction  

Event Description

Attempted to initiate arctic sun.Unable to start therapy in a timely manner.Machine alarming low flow.Attempted to trouble shoot, used all trouble shooting techniques taught to get machine to run.Machine would not run.Called trouble shooting number provided, no answer.Looked up another number for the company and no answer.Initiating therapy was delayed due to machine not working properly.Had to obtain another machine from a different unit which did work and therapy initiated 20 minutes later.It does not appear harm came to the patient as a result of equipment failure.

• Brand Name: ARCTIC SUN
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• MDR Report Key: 12391443
• MDR Text Key: 268940157
• Report Number: 12391443
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1