MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER, RI-2; PUMP INFUSION

Catalog Number	903-00039
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2024
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 was not returned to belmont for evaluation and the user confirmed that the disposable set involved in this incident was discarded therefore could not be sent for review.Although the patient involved in this incident expired, the user facility confirmed that the device did not cause or contribute to death.The user will lose the ability to infuse the patient during the issue.A 102 error message generates to alert the user of the condition of the device.Infusion can be continued through other means.There is no indication of the use of contraindicated fluids.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 will 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 system with a new disposable.Service machine if the problem persists." a message appears on the screen to discard the disposble and blood and to restart the system with a new disposable.Infusion of the patient can be continued by other means if the error persists.The biomed at the user facility confirmed that they completed a pm (preventative maintenance) on the device and it all checked out correctly.Belmont followed -up with the user facility to check if they need further assisstance with the issue but they declined and said that the device is being put back for use.The device involved in the incident was not returned for investigation therefore, device malfunction could not be verified and the root cause could not be determined.We will continue to monitor this type of incident and take further corrective and preventive actions if required.
Event or Problem Description
The user facility reported to the belmont's clinical specialist that the ri-2 generated an error 102 during a procedure.It was reported the patient involved expired, however the device was not a contributing factor.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• 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: 18862949
• Report Number: 1219702-2024-00010
• Device Sequence Number: 20892733
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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 Catalogue Number: 903-00039
• 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: 02/07/2024
• Initial Report FDA Received Date: 03/07/2024
• 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