MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER RI-2, 120V, 1000ML/MIN; THERMAL INFUSION FLUID

Model Number	903-00037
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Belmont tubing channel (diverter valve) locked in one position therefore not allowing the rn to load the tubing properly.The belmont unit had to be swapped out for another unit creating a delay in patient care for an emergent trauma patient who required blood products.There is no known harm to the patient at this time.
Additional Manufacturer Narrative
The internal complaint file # (b)(4) has been logged for this incident for traceability.The ri-2 involved in this incident was returned to belmont and evaluated.It was reported that the users were having difficulty in loading and inserting the disposable tubing.Whenever the power is off, the valve pincher is always stays far to the left instead of in the middle position.Request to send the unit back for the valve motor and pincher to be readjusted.The incident was initially reported to belmont by the user facility on august 18, 2025.However, a medsun report was received on february 02, 2026, therefore belmont will file a report.There was no report of patient harm.The valve pincher issue is obvious to the user while inserting the disposable set.Another device or alternative methods can be used to continue infusion.Through our investigation it was confirmed that the valve pincher was off-centered.The valve sensors on the daughterboard needed to be adjusted.The unit exhibited no other faults/failures.We will continue to monitor these incidents closely and take further corrective and preventive action if required.

• Brand Name: RAPID INFUSER RI-2, 120V, 1000ML/MIN
• Common Device Name: THERMAL INFUSION FLUID
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: garet tierney ; 780 boston road; billerica, MA 01821
• MDR Report Key: 24443502
• Report Number: 1219702-2026-00009
• Device Sequence Number: 10254496
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K242735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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
• Device Model Number: 903-00037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown