MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER RI-2, 120V, 1000ML/MIN; PUMP INFUSION

Model Number	903-00037
Medical Device Problem Codes	Overheating of Device (1437); Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2024
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 is not yet returned to belmont for investigation.Per medwatch user facility report mw5172017, the date of event is july 28, 2024 and the date of medwatch report is june 20, 2025 but the user facility did not inform belmont about this incident when it actually occured.Belmont became aware of this incident after receiving the medwatch report on july 14, 2025, therefore submitting this now.Belmont contacted the user facility to get additional details on the incident (including what fluids was infused, s/n number of the device, availability of the unit for investigation, lot number of disposable set involved, if any adverse patient impact etc.) and the user facility confirmed that they do not have any additional information available on the incident.An air detector alarm is generated to alert the user of the condition of the device.The operator manual states the following: "open the door to silence the alarm.Check for air bubbles and possible leaks.Squeeze the tubing directly below air detector to clear any trapped air out of the sensor.There should be no trapped air remaining within the air detector.Check the air detector and make certain that it is clean and nothing is obstructing the sensor.Reseat the tubing in the air detector and make certain that it is seated firmly in the sensor.Press reprime to reprime main system.If the system does not complete the reprime because the filter in the reservoir chamber is clogged, replace the reservoir chamber or the disposable set and reprime.The system will resume infusion upon completion of the reprime.Power off and service the machine if error persists.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 an "over temperature" alarm, the rapid infuser exhibits the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the user will lose the ability to infuse the patient during the event.To avoid similar incident in the future and ensure that ri-2 is used as per belmont's specifications, our territory manager is working with the user facility to schedule an on-site training for the device users.Belmont is working with the user facility to get the device involved in this incident returned for investigation.Without the results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigaton and on-site training is complete.
Event or Problem Description
Two belmont machine failure - on a trauma - would not deliver the blood, said air in line then over heated.
Additional Manufacturer Narrative
The cited rapid infuser and disposable set were requested for investigation but not returned to belmont for evaluation.Additional information regarding the reported event was requested but was not available.Therefore, no investigation could be carried out.The device history record could not be reviewed as the serial number was unknown.The lot number of the disposable set involved was unknown.No investigation could be carried out into the lot history of the disposable set.All disposable sets are 100% leak tested and visually inspected prior to release.No device malfunction could be verified, and the root cause of the reported issue could not be determined.A belmont clinical specialist has reached out to schedule time to review proper operation of the rapid infuser with the staff.The customer was reminded to reach out to belmont with details of the event so any reported issues can be resolved in a timely manner.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, 1000ML/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: 22798432
• Report Number: 1219702-2025-00044
• Device Sequence Number: 18283589
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: 903-00037
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/10/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 43 YR
• Patient Sex: Female