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	Insufficient Information (4580)
Date of Event	02/27/2026
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 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 march 04, 2026.It was reported that during use on an unstable trauma patient in the operating room, an attempt was made to initiate rapid transfusion using the belmont device.The unit briefly operated, and was involved in an overheating incident, with smoke observed originating from the disposable set and then shut down.Attempts to restart the unit were unsuccessful.A different ri-2 unit and a new disposable set were used to complete the case.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 april 03, 2026, a medwatch report #mw5184590 was filed for this event.Per belmonts policy, an mdr is being submitted as the event involved a user facility report.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.Additional information was received on april 03, 2026, it was reported that a patient with multiple gunshot wounds was taken emergently to the operating room for hemorrhagic shock.A massive transfusion protocol (mtp) was initiated during surgical intervention, including clamshell thoracotomy and internal cardiac massage for pulseless arrest.The primary bleeding source was identified in the pelvis and retroperitoneum, with additional vascular injuries managed intraoperatively.During use, a delay in therapy was reported due to device malfunction and the need to replace the unit.A replacement device was utilized to continue the transfusion.The patient required extensive transfusion support, including approximately 5000 ml of unmatched o+ red blood cells, 2700 ml of plasma, 600 ml of platelets, and 200 ml of cryoprecipitate certain infuses 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.Both cryoprecipitate and platelets were administered to the patient.Additional information was requested to determine whether these products were infused through the rapid infuser; however, this information was not available.These products are contraindicated for use with the device and, if infused, may have contributed to the reported overheating issue.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.The disposable set was not provided for investigation; therefore further investigation could not be performed.The lot number was unknown; therefore no investigation could be carried out into the lot history.All 3 spike disposable sets are 100% leak tested and visually inspected prior to release.We will continue to monitor these incidents closely and take further corrective and preventive action if required.
Event or Problem Description
It was reported that during use on an unstable trauma patient in the operating room, an attempt was made to initiate rapid transfusion using the belmont device.The unit briefly operated, and was involved in a overheating incident, with smoke observed originating from the disposable set and then shut down.Attempts to restart the unit were unsuccessful.A different ri-2 unit and a new disposable set were used to complete the case.No patient harm was reported.

• 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: 25058229
• Report Number: 1219702-2026-00018
• Device Sequence Number: 15977831
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 05/01/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 05/01/2026
• 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: Male