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

Model Number	FMS 2000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the rapid infuser nor the associated disposable set involved in the incident has been returned to belmont for investigation, therefore we are unable to confirm the reported smoking or subsequent fluid leak.The users were unable to provide the lot number of the disposable set.Without the ability to investigate the device or associated disposable set, it is difficult to determine what occurred in this case.Following receipt of the complaint, belmont's sales representative held a video conference with the anesthesia and or departments; as of (b)(6) 2021 it was confirmed that the device will be returned to belmont for further investigation.A review of the device history records and service reports for the rapid infuser indicate that the device reached its end of life in 2014 and has not been returned to our facility since it was shipped to the customer in 2007.There was no patient injury reported.If and when additional information becomes available, a supplemental report will be provided.
Event or Problem Description
Belmont's sales representative received a report from the user facility that the belmont rapid infuser, fms 2000 "began to smoke and the disposable began to leak blood.".

• 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: 11426362
• Report Number: 1219702-2021-00037
• Device Sequence Number: 19574423
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1