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

Model Number	FMS 2000
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser, fms 2000 involved in the incident has not been returned to belmont for investigation, therefore we are unable to confirm the report that the unit was causing the circuit breaker in the room to trip.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adapter for ungrounded outlets." it was reported that the unit failed the electrical safety analyzer in the hospital biomed department.Without the ability to investigate the unit, a root cause of the reported issue cannot be established.The service and preventive maintenance schedule provided in the operator's manual instructs the user to perform an electrical safety test every year.The manufacturing records for this serial number were reviewed and no anomalies were identified.A review of the device history records and service reports indicate that the unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in january 2015.It was reported that another rapid infuser was used to finish the case; there was no injury to the patient.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported that the belmont rapid infuser, fms 2000 was tripping the circuit breaker during a case in the emergency room.Another rapid infuser was brought in to finish the case and the patient was not harmed.The unit failed the electrical safety analyzer in the biomed department.

• 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: 11970980
• Report Number: 1219702-2021-00077
• Device Sequence Number: 11610130
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: 05/10/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1