MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number	FMS 2000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following receipt of the complaint, belmont's national sales manager and director of r&d and engineering visited the hospital and met with the hospital biomed.The unit was observed and it was determined that the source was the power cord and not the unit itself.The c19 connector was incinerated, which was the source of the soot covering the back of the system.It was noted that there was lint, dried saline, and debris inside the intake air openings.The unit was opened and there was no damage noted to the internal components.The system was subsequently turned on in battery mode, as the power cord was compromised.The unit powered up normally and all the key features were within specification.The manufacturing records for this serial number were reviewed and nothing notable was found.The routine maintenance schedule provided in the operator's manual instructs the user: "inspect the fan guards, on the bottom of the unit, for debris that might impede air flow.Remove guards by unscrewing the 4 retaining screws and clean, with soap and water, if necessary.Make certain the guards are not damaged.Let the fan guards dry before reinstalling." it was reported that there was no injury to the patient.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
The trauma nurse from the user facility reported the following: "the belmont machine was turned on and the tubing put in place and primed.The machine was turned off and a few minutes later the machine caught on fire and was put out by the staff with a fire extinguisher." it was reported that the patient was not harmed.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 8466861
• Report Number: 1219702-2019-00018
• Device Sequence Number: 16551336
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1