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

Catalog Number	903-00006
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility did not inform belmont about this incident when it occurred on october 10th, 2023, belmont became aware of this incident after receiving medwatch report # (b)(4) on december 12th, 2023.Internal complaint file # (b)(4) has been logged for this incident for traceability.The ri-2 and disposable involved in this incident were not returned to belmont for evaluation.The user facility claimed that there was a leak however the disposable in question has not been provided for review nor has the lot number of the device been provided.A leak would be obvious to the user while interacting with the device.The disposable set can be exchanged to continue infusion.No patient impact / harm has been reported.The operator's manual provides instructions on installing the disposable set and additional recommended operator actions.The step-by-step procedures in manual has warning on installing the disposable, "do not kink or twist the tubing" and "do not apply excessive pressure to the pressure transducer.The pressure transducer can be damaged with excessive force.Do not use the system if the pressure transducer is damaged".All 3-spike sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.Belmont has reached out to the risk manager (initial reporter from the user facility) on december 20, 2023 and january 4, 2024 to request the lot number and additional information about the incident but haven't received any further updates on the incident.There is no information about the lot number of the device to allow the review of device manufacturing records.Belmont will continue to follow up with the user facility to try and obtain additional information.A review of complaints will be conducted if we obtain the lot number of the device and the device history record will be reviewed.A follow-up report will be submitted once the additional information becomes available.
Event or Problem Description
The risk manager reported that while using the belmont for rapid transfusion, the tubing was inserted and was leaking.This device was removed and replaced with another set, and then worked.There was no patient harm associated with this incident.
Additional Manufacturer Narrative
The cited disposable set was requested for investigation, however it was not provided.Belmont has reached out to the risk manager (initial reporter from the user facility) on december 20, 2023, january 4, 2024 and january 12, 2024 to request the lot number and additional information about the incident but to date we have not received any response from the user facility.The complaint file will be re-opened if additional information is received.No device malfunction could 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.

• 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: 18481170
• Report Number: 1219702-2024-00002
• Device Sequence Number: 6594335
• Product Code: FRN
• UDI-Device Identifier: 10896128002029
• UDI-Public: 10896128002029
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 903-00006
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (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