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	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit was constantly exhibiting error 101.All sensors were cleaned and a new disposable was installed, however, the error persisted.No patient harm was reported.
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 investigation on september 30, 2025.The incident was initially reported to belmont by the user facility on september 11, 2025.It was reported that the unit was constantly exhibiting error 101.All sensors were cleaned and a new disposable was installed, however, the error persisted.No patient harm was reported.Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, we received a medsun report # (b)(4) on september 22.2025 related to the same incident.As per belmont's procedure, a report is now 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 system error #101, the rapid infuser displays the following alarm message, "check temperature probes for blockage.Clean windows.Press retry to continue.Service machine if error persists.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.The cited rapid infuser was evaluated by engineering.The reported issue could not be confirmed after extensive testing and no errors were found.The input and output temperature probes were inspected, and no abnormalities were identified that would have contributed to the reported error.No device malfunction could be verified with unit, and the root cause of the reported error 101 could not be determined.The device history was reviewed, and no similar incidents 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, MA 01821
• MDR Report Key: 23359055
• Report Number: 1219702-2025-00063
• Device Sequence Number: 15668760
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 10/22/2025
• 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 Age: 38 YR
• Patient Sex: Female