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

Catalog Number	903-00039
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint file #(b)(4) has been logged for this incident for traceability.The ri-2 involved in the incident was returned to belmont medical technologies for evaluation on september 07, 2023.There is no patient involvement in this event since it occurred during an educational training.Upon receipt, the device was evaluated by a belmont service technician and the complaint was confirmed.It was found that fluid entered the power entry which led to the reported issue of a burned power entry module.A locking power cord without a moisture guard was being utilized during the event which allowed fluid to enter the device.It was also identified that the unit had a cracked plastic cover on the door.The unit exhibited no other faults/failures.The root cause was ingress of fluids over the power entry while locking cord without a moisture guard was used.The device should be protected from spillage, any spillage should be promptly cleaned up.In addition it was observed that a moisture guard which is provided with a non locking power cord has been placed on a locking cord originally supplied with the device.We are unable to determine as to why the incorrect cords without the moisture guard were not replaced by the correct power cords that were shipped to the user facility by belmont in november 2021.We replaced the locking power cord with a new cord with a moisture shield to resolve the reported issue.We also replaced the power entry module, plastic cover on the door and cleaned the unit.In addition, we upgraded the system to the current revision and performed a routine calibration of the system.To ensure that this unit performs according to our specifications before shipping it back to you, we operated the unit at elevated temperatures for 48 hours and we performed a final functional test, an electrical safety test, and a final inspection.The unit passed all test specifications and inspection requirements.The user facility was reminded 9/13 to inspect the other ri-2s at hospital to verify that power cords used with the ri-2s are nonlocking cords with a moisture guard.Belmont will continue to monitor this issue moving forward.
Event or Problem Description
The user facility reported that during an educational training, it is alleged that the device caught fire at the back of the unit where the power cord is plugged in.There were signs of fluid leaking, but the staff was uncertain where from.On august 31st, the user facility confirmed that there was no leaking from the disposable set.There was no patient involvement in this event since the event occurred during training.

• 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: 17802878
• Report Number: 1219702-2023-00049
• Device Sequence Number: 7379966
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/22/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown