MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION THE BELMONT RAPID INFUSER; WARMER, THERMAL, INFUSION FLUID

Model Number FMS 2000

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2015

Event Type  malfunction  

Event Description

The rapid infusion device being used to infuse blood into a patient caught fire and filled the operating room with smoke.The device was disconnected and pushed it into the hall outside operating room.Once disconnected the belmont infuser stopped smoking.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston rd; billerica MA 01821
• MDR Report Key: 5245578
• MDR Text Key: 31984856
• Report Number: 5245578
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: FMS 2000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR