MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER RI-2, 230V, 1000 ML/MIN; PUMP INFUSION

Model Number	903-00037A
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file#: (b)(4) has been logged for this incident for traceability.It was reported that during an ec administration, the rapid infuser automatically increased the flow rate to 500 ml/min on five separate occasions, despite the set flow rate being 50 ml/min.During each occurrence, the change in flow was detected by the user based on the noise generated by the device when they had stepped away.There was no patient injury.The device was taken out of service following the event and replaced with another unit.Belmont was also informed that a user facility report has been filed, as per belmont's procedure, a report is being submitted.After every 500 ml of fluid infused, the system automatically purges air from the system by closing the infusion line and opening the recirculation line for a few seconds.The recirculate rate is temporarily set to 500 ml/min, if the flow rate is at or below 500 ml/min, and at the actual flow rate, if the flow rate is above 500 ml/min.The rate status line displays removing air during this process.The volume readout (vol) remains unchanged during automatic air purging and resumes counting when infusion resumes.When infusion resumes, the system returns to the previously set rate.The ri-2 operators manual states that the ri-2 should not be left unattended while in operation.Belmont has requested the customer to have the device tested on site or returned for evaluation.The device history was reviewed, and no other issues were identified.Without the 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
It was reported that during an ec administration, the rapid infuser automatically increased the flow rate to 500 ml/min on five separate occasions, despite the set flow rate being 50 ml/min.During each occurrence, the change in flow was detected by the user based on the noise generated by the device when they had stepped away.There was no patient injury.The device was taken out of service following the event and replaced with another unit.
Additional Manufacturer Narrative
The cited rapid infuser was evaluated by the distributor following the reported concern that the flow rate was changing automatically during use.The device underwent extensive functional testing, including display evaluation, internal inspection, and a full system operational checkout.No anomalies or abnormalities were identified, and the unit passed all testing with no issues.The reported issue could not be reproduced.According to the operator manual, after every 500 ml of fluid infused, the system automatically purges air from the system by closing the infusion line and opening the recirculation line for a few seconds.The recirculate rate is temporarily set to 500 ml/min, if the flow rate is at or below 500 ml/min, and at the actual flow rate, if the flow rate is above 500 ml/min.The rate status line displays removing air during this process.The volume readout (vol) remains unchanged during automatic air purging and resumes counting when infusion resumes.When infusion resumes, the system returns to the previously set rate.It was reported that the flow rate was set to 50 ml/min.The frequency of the reported events is consistent with the automatic air purging cycle occurring approximately every 500 ml infused (within 15 minutes).The device history of this unit was reviewed, and no other issues were identified.The customer was reminded of the automatic air purging that occurs every 500 ml infused.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, 230V, 1000 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 01821
• MDR Report Key: 23621597
• Report Number: 1219702-2025-00068
• Device Sequence Number: 21074958
• Product Code: FRN
• UDI-Device Identifier: 10896128002753
• UDI-Public: 10896128002753
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 903-00037A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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