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

Model Number	903-00037
Medical Device Problem Codes	Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during clinical use as part of a massive transfusion protocol (mtp), the device began emitting smoke.The device was immediately removed from service.
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.It was reported that during clinical use as part of a massive transfusion protocol (mtp), the device began emitting smoke.The device was immediately removed from service.Subsequently, belmont was informed that the patient expired, however, it was confirmed that the device was not a contributing factor as they were able to resume the mtp after switching to new device with no further incidents.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 power cord not plugged in ac power, the rapid infuser displays the following alarm message: "battery no heating." to indicate the system is now in battery mode and heating is suspended.The maximum flow rate is 50ml/min, and heating is suspended.The operator's manual also provides possible conditions and additional recommended operator actions: "plug into ac receptacle; check power cord connection.Keep the system plugged in to charge the battery".The operator's manual also has caution: "battery operation should be used only briefly or at very low flow rates because there is no heating".During a site visit on (b)(6) 2026, additional information was obtained indicating that the device was initially used in labor and delivery for approximately 40 minutes without issue.The same disposable set was then used to transport the patient to the icu, where infusion resumed for an additional 40 minutes.During use in the icu, staff reported detecting a burning odor and observing smoke, along with blood leaking from the bottom of the device.The infusion was immediately discontinued, and an alternative device was used to continue.The clinical team reported that only compatible fluids were administered through the device.The device has not yet been returned to belmont for investigation.Without the results of the device investigation, no conclusions can be drawn at this time.A follow-up report will be submitted once the investigation is complete and additional information becomes available.

• 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, MA 01821
• MDR Report Key: 24720309
• Report Number: 1219702-2026-00014
• Device Sequence Number: 6088263
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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
• Device Model Number: 903-00037
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown