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

Model Number	903-00037A-G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
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 the incident has not been returned to belmont medical technologies for evaluation.The restart is obvious to the user while interacting with the touchscreen of the unit.Another device or other means can be used to initiate treatment.In this case another ri-2 device was used.The user confirmed that the alleged incident occurred during set up and there was no patient impact.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.Belmont has requested the return of the device in order to investigate the alleged incident.No other complaints of this kind have been received.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
Patient with hemorrhagic shock should be treated with the rapid infusion device.After pressing the softkeys "fullen" on the screen will restart the device again and again up to this point.The treatment had to be carried out with an identical replacement device.
Additional Manufacturer Narrative
The cited device was returned and evaluated by a belmont service technician.It was found that the reported fault could not be replicated after thorough testing and evaluation.The device was able to function correctly when pressing the prime button without restarting.Although a restart could be confirmed from the provided video, the reported issue could not be replicated and no device malfunction could be verified.The device history was reviewed and no other issues were identified.

• Brand Name: GERMAN, 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 21665446
• Report Number: 1219702-2025-00020
• Device Sequence Number: 7755857
• Product Code: FRN
• UDI-Device Identifier: 40896128002754
• UDI-Public: 40896128002754
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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: 903-00037A-G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• 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