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	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser was returned for investigation and was tested using our standard operating procedures.We were unable to duplicate the customer complaint regarding an over temperature (overtemp) alarm; however, upon receipt we found a damaged capacitor on one of the driver boards, which caused the unit to exhibit a "heater power i/o fault" alarm.We were unable to investigate the disposable set, as neither the sample nor lot number was provided.We have reached out to the user facility 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.The manufacturing records for this serial number were reviewed and nothing notable was observed.The unit had not been returned to belmont for servicing since it was initially shipped to the customer in 2012.Without additional information, it is difficult to determine what occurred in this case.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The user facility reported that the rapid infuser experienced an "overtemp" alarm after a few hours into a case.The unit was subsequently brought to the biomed lab and began exhibiting a constant "heater power i/o fault" alarm.

• 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: 9644353
• Report Number: 1219702-2020-00006
• Device Sequence Number: 2500334
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: 01/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1