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

Model Number	903-00037A
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ri-2 unit powered on and the led indicator flashed; however, the display remained blank.The device had been in use for an extended period during a massive transfusion, during which approximately five massive transfusion packs were administered using blood products compatible with the ri-2.After the issue occurred, a replacement belmont unit from theatre was temporarily used.The patient later died due to significant injuries; the user facility confirmed that the patient's death was not related to the ri-2 device or its temporary unavailability.
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 an ri-2 unit powered on and the led indicator flashed; however, the display remained blank.The device had been in use for an extended period during a massive transfusion, during which approximately five massive transfusion packs were administered using blood products compatible with the ri-2.After the issue occurred, a replacement belmont unit from theatre was temporarily used.The patient later died due to significant injuries.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 see the screen of the ri-2 during the event.This is visibly obvious to the user while interacting with the unit.Another device or alternate methods can be used to continue infusion.The cited ri-2 was returned to belmont for investigation and is currently undergoing evaluation.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The cited unit was evaluated by belmont technical service.Through our investigation it was confirmed that the unit powered up with a blank display.After internal inspection it was determined that the display was damaged due to fluid ingress through the screen.The root cause was isolated to fluid ingress.The device history was reviewed and no other issues were identified.The top display module assembly of the unit was replaced to resolve the issue.The device then passed full preventative maintenance and functional testing with no issues.We will continue to monitor these incidents closely and take further corrective and preventive action if required.

• 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 01821
• MDR Report Key: 24369312
• Report Number: 1219702-2026-00006
• Device Sequence Number: 4914164
• Product Code: FRN
• UDI-Device Identifier: 10896128002753
• UDI-Public: 10896128002753
• 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,Followup
• Report Date (Section B): 03/18/2026

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
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/18/2026
• 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