MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER RI-2, 120V, 750 ML/MIN; PUMP, INFUSION

Model Number	903-00039
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2026
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.It was reported that the unit lost power in the middle of the case and shut off immediately and the patient expired.It cannot be determined at this time if the device contributed to the patient death.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".Belmont has contacted the user facility for additional information; however, a response has not yet been received.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.
Event or Problem Description
It was reported that the unit lost power in the middle of the case and shut off immediately.No other details were provided except that the patient passed away.
Additional Manufacturer Narrative
The cited device involved in the incident, as well as additional information regarding the event were requested, but were not made available for investigation.Therefore, no investigation could be carried out.We are unable to verify any device malfunction, and the root cause of the reported issue cannot be determined.The device history of this unit was reviewed, and no other issues were identified.It is unclear if the reported device issue caused or contributed to the death without the return of the device and the additonal information requested from the user facility.We will continue to monitor these incidents closely and take further corrective and preventive action if required.

• Brand Name: RAPID INFUSER RI-2, 120V, 750 ML/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: 24578696
• Report Number: 1219702-2026-00013
• Device Sequence Number: 10474811
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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: 903-00039
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/30/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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