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

Model Number	903-00037
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint file (b)(4) has been logged for this incident for traceability.The ri-2 and disposable involved in the incident have not yet been returned to belmont medical technologies for evaluation.The user indicated that air was removed by hand and the device operated properly.There was no patient harm associated with this event.All disposable sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.Belmont is working with the user facility to get the device involved in this incident returned for investigation.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Event or Problem Description
The biomed reported that, "belmont rapid infuser ri-2 having, sn: (b)(6), ref 903-00039 recently had an issue where a line into the reservoir clotted off.When the intake clotted off, a significant amount of air was entrained into the system.It was not caught by the air sensor and made it into the patient line.The machine was stopped prior to it going to the patient.The air was removed by hand and the machine operated properly.
Additional Manufacturer Narrative
Upon receipt of the referenced rapid infuser ri-2 unit, the device was evaluated by a belmont service technician, and we were unable to confirm the cited air in line error after extensive functional testing and stress testing at elevated temperature for 48 hours.The unit exhibited no faults/failures.The device history was reviewed for this unit, and no other issues were identified.To ensure that this unit performs according to our specifications before shipping it back, we performed a final functional test, an electrical safety test, a battery test, and a final inspection.The unit passed all test specifications and inspection requirements.It was found the reported issue could not be confirmed after extensive functional testing.The air detector alarm functioned with no issue.No device malfunction could be verified and the root cause could not be determined.We will continue to monitor these incidents going forward.

• Brand Name: RAPID INFUSER RI-2, 120V, 1000ML/MIN
• Common Device Name: THERMAL INFUSION FLUID
• 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: 21536172
• Report Number: 1219702-2025-00016
• Device Sequence Number: 15387325
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/30/2025

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: 02/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown