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	Smoking (1585)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to belmont that there was a smoking incident with the ri-2.Additional information was provided on 8/17 that the patient involved expired.
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The ri-2 and disposable have not yet been returned to belmont for investigation.It was reported to belmont that there was a smoking incident with the ri-2.Additional information was provided on 8/17 that the patient involved expired.The device did not cause or contribute to the death as treatment was continued with a second device.Belmont is filing a report as per procedure.Belmont was informed the unit and disposable set are quarantining at the site in biomedical engineering.Belmont has offered retraining to the customer, however the site has declined.Additional information such as a photo of the disposable has been requested from the site but has yet to be provided.The lot number is unknown.Belmont has requested the device and disposable set to be returned for evaluation once they are released from quarentine.Certain infusates such as calcium, and platelets should not be used, as they can compromise the anticoagulants in citrated blood and promote clotting, which can lead to clot formation inside the heat exchanger and block blood flow.If this occurs, the stainless steel rings inside the heat exchanger may become overheated.In case of overheat alarm, 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.Other methods can be used to infuse the patient.Without results of the device and disposable investigation, no conclusions can be drawn at this time.A follow-up report will be submitted once the investigation is complete.

• 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: 50867693
• Report Number: 1219702-2026-00029
• Device Sequence Number: 13106362
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K242735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2026
• 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: 29 YR
• Patient Sex: Unknown