MAUDE Adverse Event Report: Belmont Medical Technologies Rapid Infuser RI-2, 230V, 1000 ml/min; Infusion Pump

Model Number	903-00037A
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the ri-2 was used to administer blood products and fluids for volume resuscitation.Repeated high-pressure alarms occurred, resulting in difficulty delivering the required fluid.Inspection identified a kink in one foot cannula and reisstance in a second cannula, which required manual flushing to establish patency.Although both cannulas were subsequently able to be flushed manually, repeated high-pressure alarms continued on the ri-2.
Additional Manufacturer Narrative
The internal complaint file (b)(4) has been logged for this incident for traceability.The distributor confirmed the device passed testing and is back in use.We are waiting for the disposable set to return to belmont.It was reported that during a procedure, the ri-2 was used to administer blood products and fluids for volume resuscitation.Repeated high-pressure alarms occurred, resulting in difficulty delivering the required fluid.Inspection identified a kink in one foot cannula and reisstance in a second cannula, which required manual flushing to establish patency.Although both cannulas were subsequently able to be flushed manually, repeated high-pressure alarms continued on the ri-2.It was reported the patient involved expired, however there was no report the device casued or contributed to the death.As per belmont's procedure, a report is being filed.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.A high pressure alarm is generated to alert the user of the condition of the device.The operator manual states the following: "make certain that the flow path is not blocked.Check that the recirculate line is not obstructed.Check that the infusion site is well placed and use the appropriate infusion set recommended in the guide, match the infusion set to flow rate and fluid type on page 10.Increase pressure limit setting.Press next to silence the alarm and resume.Check functionality of the pressure transducer by gently pressing the transducer.Pressure reading on screen should change.If not, it is defective, service machine."infusion of the patient can be continued by other means if the error persists.Without results of the disposable set investigation, no conclusions can be drawn at this time.A follow-up report will be submitted once the disposable set is returned and the investigation is complete.

• Brand Name: Rapid Infuser RI-2, 230V, 1000 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: garet tierney ; 780 boston road; billerica, MA 01821
• MDR Report Key: 50820547
• Report Number: 1219702-2026-00027
• Device Sequence Number: 13301430
• Product Code: FRN
• UDI-Device Identifier: 10896128002753
• UDI-Public: 10896128002753
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 903-00037A
• 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
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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