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

Model Number	903-00037A-UK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2026
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 been returned to belmont medical technologies for evaluation.It was reported that the ri-2 was set up for use in an emergency and primed with saline.After approximately 30 seconds, the device displayed an unspecified error message.The system was powered off and then restarted.Following restart, blood products were infused for approximately 10-15 minutes.The patient later died; however, the user facility confirmed that the device did not contribute to the patient's death.As per belmont's procedure, a report is being submitted.The user will lose the ability to infuse the patient with the device during the issue.An alarm generates to alert the use of the condition of the device.Another device with separate disposable set can be used to continue treatment.Alternate methods can also be used to infuse the patient.The rapid infuser involved in the incident was functionally tested by belmont and passed with no issues.No device malfunction could be verified, and the root cause of the reported incident could not be determined.The device history of the unit was reviewed, and no similar issues were identified.We will continue to monitor these incidents closely and take further corrective and preventive action if required.
Event or Problem Description
It was reported that the ri-2 was set up for use in an emergency and primed with saline.After approximately 30 seconds, the device displayed an unspecified error message.The system was powered off and then restarted.Following restart, blood products were infused for approximately 10-15 minutes.The patient later died; however, it was confirmed that the patient death was not related to the ri-2 system or the disposable set.

• Brand Name: RAPID INFUSER RI-2, 230V, 1000 ML/MIN
• Common Device Name: INFUSION PUMP
• 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: 24405827
• Report Number: 1219702-2026-00007
• Device Sequence Number: 21296843
• Product Code: FRN
• UDI-Device Identifier: 00896128002800
• UDI-Public: 00896128002800
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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-UK
• 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: 01/23/2026
• Initial Report FDA Received Date: 02/20/2026
• 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