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

Model Number	903-00039
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a massive transfusion protocol (mtp), approximately 5-10 minutes into rapid blood transfusion, the device began emitting smoke and the disposable set was observed to be melted.
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The incident was initially reported to belmont by the user facility on (b)(6) 2025.According to the report during a massive transfusion protocol (mtp), approximately 5-10 minutes into rapid blood transfusion, the device began emitting smoke and the disposable set was observed to be melted.No patient harm was reported.Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, belmont was informed on december 10, 2025, that the patient expired, however, it was confirmed that the device did not contribute to the death as the patient expired due to previously sustained injuries.As per belmont's procedure, a report is being submitted.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.The cited ri-2 was evaluated by belmont technical service.The reported issue could not be confirmed after extensive testing at different flow rates and fluid temperatures.Belmont inspected the input and output temperature probes as well as the bobbin assembly, and no faults were identified.The device history of the unit was reviewed, and no similar issues were identified.The disposable set involved was not returned for investigation.The lot number of the disposable set involved was unknown, therefore a thorough investigation into the lot history could not be carried out.All disposable sets are 100% leak tested and visually inspected prior to release.No device malfunction could be verified, and the root cause of the reported issue could not be determined.The customer was provided re-training to ensure they are comfortable utilizing the unit and are familiar with compatible solutions.We will continue to monitor these incidents going forward.

• Brand Name: RAPID INFUSER RI-2, 120V, 750 ML/MIN
• Common Device Name: INFUSION PUMP
• 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: 23993283
• Report Number: 1219702-2025-00070
• Device Sequence Number: 13361843
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 01/07/2026
• 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