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 Information (3190)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser was returned to belmont for investigation and was tested using our standard operating procedures.We were unable to duplicate the customer complaint that the unit "overheated" after stress testing at elevated temperatures for 48 hours.However, upon receipt, it was noted that the fan guards needed to be replaced.The service and preventive maintenance schedule provided in the operator's manual instructs the user to inspect and clean the fan guards once a month, as a build-up of debris can impede air flow.The following instructions are provided in the manual: "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." the manufacturing records for this serial number were reviewed and nothing notable was found; the unit had not been returned to belmont since it was shipped to the customer in 2005.The disposable set was not returned for evaluation, nor was a lot number provided.We will continue to reach out to the user facility to try to determine the lot number of the disposable set, as well as the type of infusate used during the procedure.Certain infusates are contraindicated and may lead to clot formation inside the heat exchanger, which can block blood flow and result in an "over temperature" alarm.This alarm will cause the system to shut down, as it is designed to do.When the rapid infuser recognizes a situation that may compromise safe and effective infusion, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The biomed at the user facility reported that the rapid infuser "overheated" during a case.

• 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: 9132383
• Report Number: 1219702-2019-00068
• Device Sequence Number: 14148742
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/28/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1