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

Model Number	903-00037
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fire occurred at the back of the ri-2 unit at the ac power entry location.There was no patient involvement and the system was not in clinical use at the time of the event.
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 been returned to belmont medical technologies for evaluation.It was reported that a fire occurred at the back of the ri-2 unit at the ac power entry location.There was no patient involvement and the system was not in clinical use at the time of the event.There were no injuries reported.A report is being submitted as this event represents a potential hazard.The ri-2 is compliant with iec-60601-1 for flammability resistance.The operator's manual provides the following warning statement: "prime the main system with solution compatible with blood.Do not prime with blood and a caution that: "immediately wipe any spills from the device".In order to avoid any such event, the spills must be wiped from the device.The operator's manual also instructs to "check the power cord before or after each use".Belmont is working with the user facility to 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.
Additional Manufacturer Narrative
The cited rapid infuser was evaluated by belmont engineering and technical service.After visual inspection,it could be confirmed there was a high energy event from the presence of char marks at the power entry of the unit and the power cord.This was caused by fluid ingress into the power cord's c19 connector.The root cause was isolated to fluid ingress into the power entry.The device history was reviewed, and no similar issues were identified.We replaced power entry module assembly and the power cord.To ensure that this unit performs according to our specifications before shipping it back, we operated the unit at elevated temperatures for 48 hours and we performed a final functional test, an electrical safety test, and a final inspection.The unit passed all test specifications and inspection requirements.A belmont territory manager will be going to the customer site to ensure periodic maintenance of the devices.We will continue to monitor this type of incident closely and take further corrective and preventive action if required.

• 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: 23475710
• Report Number: 1219702-2025-00066
• Device Sequence Number: 21389418
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 12/12/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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