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	Complete Loss of Power (4015)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2025
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 on feb 27th, 2025, which is ongoing.The incident was initially reported to belmont by the user facility on feb 10th, 2025 that the unit shut down during a procedure.No details are available.Belmont documented the incident to be non-reportable at that point.Subsequently, belmont was informed on (b)(6) that there was delay in treatment, however it cannot be determined at this time if the device contributed to it, which per our procedure requires us to submit a 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 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 in to 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".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 and additional information becomes available.
Event or Problem Description
The users reported that the unit shut down during a procedure.No details is available.Due to the patient involvement, the unit is under risk management control.
Additional Manufacturer Narrative
The device was tested by a belmont service technician.It was found the device did not shut down during evaluation, however the batteries inside the unit did not hold charge.This may have led to the reported shutdown.Root cause could be isolated to the batteries.No other issues were found during testing.The device history was reviewed, and no other issues were identified.The batteries were replaced to resolve the issue.To ensure that the unit performs according to our specifications before shipping it back, we performed a routine calibration of the system, operated the unit at elevated temperature for 48 hours.Upon completion, a final functional test, an electrical safety test, and a final inspection were performed.The unit passed all test specifications and inspection requirements.The device was not serviced by belmont since it was manufactured in 2021.The customer was reminded to replace the batteries when the operating time is marginal or after 3 years.

• 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 21665263
• Report Number: 1219702-2025-00019
• Device Sequence Number: 7624844
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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