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

Model Number	903-00037
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2025
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 this incident is not yet returned to belmont for investigation.Although the patient involved in this incident expired, there are no allegations that the device caused or contributed to the patient death.A 102 error message is generated to alert the user of the condition of the device.Infusion can be continued through other means.Belmont contacted the initial reporter to get additional details on the incident (including what was infused, flow rate, if device malfunction caused or contributed to the patient outcome etc.), but haven't received any further updates on the incident.Certain infusates such as calcium, and platelets should not be used, as they can compromise the anticoagulants in citrated blood and promote clotting, which can lead to clot formation inside the heat exchanger and block blood flow.If this occurs, the stainless steel rings inside the heat exchanger may become overheated and cause an over temperature /overheating issue.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.A 102 alarm is generated to alert the user of the condition of the device.The operator manual states the following: "check disposable set and flow path for occlusions.Make certain the windows on the disposable set and the ir probes are clean and dry.Clean surfaces with moistened soft cloth if necessary.Dry off surfaces before continuing.Make sure bag clamps are open and flow is unimpeded.Make sure that the filter is not clogged.Add more fluid, if fluid out.Clamp off the bag spikes and patient line and remove disposable.Power off and restart the system with a new disposable.Service machine if the problem persists." a message appears on the screen to discard the disposable and blood and restart the system with a new disposable.Infusion of the patient can be continued by other means if the error persists.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, the unit was having error 102 during over temp incident with the patient during a case.There is no details except for the patient passed away.
Additional Manufacturer Narrative
The device was reviewed by a belmont service technician.It was identified that one pin of the sensor on the input temperature probe had an intermittent connection, which caused the unit to exhibit an over temperature error (error 102).Root cause was isolated to an intermittent connection of the sensor.The device history was reviewed, and no similar issues were identified.Belmont contacted the user facility requesting additional information on the event on following dates- may 6th, may 28th and june 12th but have not received any additional details.We resoldered one pin on the input temperature probe sensor and performed a routine calibration of the system to resolve the reported issueto ensure that the unit performs according to our specifications before shipping it back, we performed a routine calibration of the system, operated the unit at elevated temperature for 48 hours.Upon completion, a final functional test, an electrical safety test, and a final inspection were performed.The unit passed all test specifications and inspection requirements.We will continue to monitor these incidents going forward.

• 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 22131799
• Report Number: 1219702-2025-00029
• Device Sequence Number: 15282527
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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
• Patient Sex: Unknown