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

Model Number	FMS 2000
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2021
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.When the rapid infuser detects a situation that is compromising effective infusing, 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.In the event of a "heating fault" alarm, the rapid infuser exhibits the following alarm message: "check temperature probes for blockage.Clean windows.Press retry to continue.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.The temperature probes should be cleaned before or after each use according to the service and preventive maintenance schedule and instructions provided in the operator's manual, as dirty, wet, or blocked temperature probes can cause the rapid infuser to exhibit a "heating fault" alarm.Without the benefit of the device back at our facility for investigation, the root cause of the alarm cannot be determined.It was reported that another rapid infuser was brought in to finish the case; there was no injury to the patient.The manufacturing records for this serial number were reviewed and no anomalies were identified.The unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2015.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported that the rapid infuser, fms 2000 exhibited a "heating fault" alarm during a case.Another rapid infuser was brought in to finish the case; there was no harm to the patient.

• 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: 11741196
• Report Number: 1219702-2021-00060
• Device Sequence Number: 4219980
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/28/2021

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1