MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER RI-2, 230V, 750 ML/MIN; PUMP, INFUSION

Model Number	903-00039A-UK
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, despite being plugged into ac power, the device would not deliver fluid at a rate above 50 ml/min and did not provide heating.The display indicated "battery, no heating." the user confirmed multiple times that the unit was properly connected to ac power.It was also reported that on a separate occasion, there was difficulty initiating operation of the device.
Additional Manufacturer Narrative
The internal complaint file # (b)(4) has been logged for this incident for traceability.It was reported that, despite being plugged into ac power, the device would not deliver fluid at a rate above 50 ml/min and did not provide heating.The display indicated "battery, no heating." the user confirmed multiple times that the unit was properly connected to ac power.It was also reported that on a separate occasion, there was difficulty initiating operation of the device.On (b)(6) 2026, the customer reported that the patient expired.On (b)(6) 2026, additional information was received indicating that the device did not cause or contribute to the patient's death.As per belmont's procedure, a report is now being submitted.In the event of power cord not plugged in ac power, the rapid infuser displays the following alarm message: "battery no heating." to indicate the system is now in battery mode and heating is suspended.The maximum flow rate is 50ml/min, and heating is suspended.The operator's manual also provides possible conditions and additional recommended operator actions:" plug into ac receptacle; check power cord connection.Keep the system plugged into charge the battery".The operator's manual also has caution: "battery operation should be used only briefly or at very low flow rates because there is no heating." the cited ri-2 was evaluated by belmont technical service.The reported issue of no ac power could not be verified after extensive testing.The device was system tested and passed with no issues.The device history was reviewed and no similar issues were identified.The customer reported that a probable cause of the issue was user error from the power cord not being fully seated leading to the device running on battery power.The root cause is consistent with user error.A belmont service technician visited the site for additional training on the ri-2.We will continue to monitor these incidents closely and take further corrective and preventive action if required.

• Brand Name: RAPID INFUSER RI-2, 230V, 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: 25112637
• Report Number: 1219702-2026-00019
• Device Sequence Number: 16037027
• Product Code: FRN
• UDI-Device Identifier: 00896128002817
• UDI-Public: 00896128002817
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: 903-00039A-UK
• 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: 03/25/2026
• Initial Report FDA Received Date: 05/07/2026
• 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