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

Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file # (b)(4) has been logged for this incident for traceability.The ri-2 involved in the incident has not yet been returned to belmont medical technologies for evaluation.Per medwatch user facility report #mw5184987, the date of event is (b)(6) 2026 but the user facility did not inform belmont about this incident when it occurred.Belmont became aware of this incident after receiving the medwatch report on (b)(6) 2026 therefore submitting the report now.It was reported that during a liver transplant procedure, the patient was on an active massive transfusion protocol for most of the 10-12 hour case.The belmont rapid infuser was running for over 8 hours when it began to emit smoke.The device was immediately replaced and sent to the biomedical team for evaluation.The issue could not be reproduced.Visual inspection identified scorching of the heating coil within the disposable.It was also reported that the patient expired; however, it is currently unclear if the device was a contributing factor.As per belmont's procedure, a report is being submitted.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 an "over temperature" alarm, the rapid infuser exhibits the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the user will lose the ability to infuse the patient during the event.Belmont contacted the user facility to get additional details on the incident (including what fluids was infused, s/n number of the device, availability of the unit for investigation, lot number of disposable set involved.) but we haven't received any response as of yet.Belmont is working with the user facility to gather additional details on the event and get the device involved in this incident returned for investigation.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Event or Problem Description
It was reported that during a liver transplant procedure, the patient was on an active massive transfusion protocol for most of the 10-12 hour case.The belmont rapid infuser was running at 750 ml/hr for over 8 hours when it began to emit smoke.The device was immediately replaced and sent to the biomedical team for evaluation.The issue could not be reproduced.Visual inspection identified scorching of the heating coil within the disposable.

• Brand Name: RAPID INFUSER RI-2, 120V, 1000ML/MIN
• Common Device Name: PUMP, INFUSION
• 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: hiba inayath sharief ; 780 boston road; billerica 01821
• MDR Report Key: 24851791
• Report Number: 1219702-2026-00015
• Device Sequence Number: 8825792
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (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: 37 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Race: White