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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file #(b)(6) has been logged for this incident for traceability.The ri-2 involved in this incident was returned to belmont for evaluation.The user confirmed that the disposable set involved in this incident was discarded therefore could not be sent for review.The incident was initially reported to belmont by the user facility on (b)(6) 2025.It was reported that during a case in which belmont ri-2 was being used for a massive transfusion, the unit experienced an overheating incident and exhibited error 102, resulting in the delay in transfusion.A second unit was brought in to complete the procedure.No patient harm was initially reported.Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, belmont was informed on (b)(6) 2025 that the patient expired.The user facility confirmed that the device did not contribute to the patient's death, the patient expired due to previously sustained injuries.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 an "over temperature" alarm, the rapid infuser exhibits the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the user will lose the ability to infuse the patient during the event.A 102 alarm is generated to alert the user of the condition of the device.The operator manual states the following: "check disposable set and flow path for occlusions.Make certain the windows on the disposable set and the ir probes are clean and dry.Clean surfaces with moistened soft cloth if necessary.Dry off surfaces before continuing.Make sure bag clamps are open and flow is unimpeded.Make sure that the filter is not clogged.Add more fluid if fluid out.Clamp off the bag spikes and patient line and remove disposable.Power off and restart system with a new disposable.Service machine if the problem persists." a message appears on the screen to discard the disposable and blood and to restart the system with a new disposable.Infusion of the patient can be continued by other means if the error persists.The cited ri-2 was returned to belmont for investigation and is currently undergoing evaluation.The disposable set was discarded and could not be sent for investigation.The lot number of the disposable set was not provided, therefore, an investigation into the lot history could not be carried out.All disposable sets are 100% leak tested and visually inspected prior to release.Without 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.
Event or Problem Description
It was reported that during a case in which belmont ri-2 was being used for a massive transfusion, the unit experienced an overheating incident and exhibited error 102, resulting in the delay in transfusion.A second unit was brought in to complete the procedure.
Additional Manufacturer Narrative
The cited rapid infuser was evaluated by belmont engineering and technical service.It was found the reported overheat could not be reproduced after extensive testing at multiple different flow rates and water temperatures.The input and output temperature probes were visually inspected, and no issues were identified that would have contributed to the overheating event.The device was internally inspected, and no anomalies were identified.The disposable set involved was discarded and the lot number was unknown.No investigation could be carried out into the disposable set and lot history.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 error could not be determined.The device history was reviewed, and no similar issues were identified.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.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, 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 01821
• MDR Report Key: 23437655
• Report Number: 1219702-2025-00065
• Device Sequence Number: 15591525
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/03/2025

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: 903-00039
• Device Catalogue Number: 903-00039
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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