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

Model Number	FMS 2000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was returned for investigation and was tested using our standard operating procedures.Upon receipt, it was found that two transistors and a capacitor on one of the driver boards were damaged, which caused the unit to exhibit a "heater power readback fault" alarm.This can occur when there is a power feedback circuit malfunction.The alarm message on the screen instructs the user: "restart system and retry.Service machine if error persists." the operator's manual also instructs the user to "power down and service machine if error persists." the unit had not been returned to belmont for servicing since it was initially shipped in 2015 and we therefore have no service history for this unit.The manufacturing records for this serial number were reviewed and nothing notable was observed.The components were replaced and the unit was returned to the distributor.It was reported that there was no injury to the patient.
Event or Problem Description
Our distributor received a complaint from the user facility and reported that the unit was infusing for 2 hours at 150 to 250ml/min during cardiovascular surgery and exhibited a "heater readback fault" alarm at the end of the process.The unit continuously exhibited the same alarm after it was restarted.

• 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: 8787359
• Report Number: 1219702-2019-00046
• Device Sequence Number: 1999096
• Product Code: LGZ
• UDI-Device Identifier: 20896128002019
• UDI-Public: (01)20896128002019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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-J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1