MAUDE Adverse Event Report: BELMONT INSTRUMENT LLC RAPID INFUSER RI-2, 120V, 750 ML/MIN; WARMER, THERMAL, INFUSION FLUID

Model Number	903-00039
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.

• Brand Name: RAPID INFUSER RI-2, 120V, 750 ML/MIN
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT INSTRUMENT LLC; 780 boston rd; billerica MA 01821
• MDR Report Key: 24229702
• Report Number: 24229702
• Device Sequence Number: 15999391
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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: 903-00039
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026