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	Insufficient Information (4580)
Date of Event	07/06/2023
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 and disposable involved in this incident were not returned to belmont for evaluation.The user 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 photograph was provided with the claimed location of a leak however no leak is evident via that photograph.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 user on (b)(6 2023 and (b)(6) 2023 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 to try and obtain additional information.A review of complaints will be conducted if we obtain the lot number of the device, testing will be conducted on a retain sample 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
Belmont received mhra (uk) report (b)(4), which detailed that the 3 spike disposable set was leaking.A photograph was provided that indicates a claimed position of a leak however no leak is actually evident on the photograph.No patient injury is indicated and no lot number was provided.
Additional Manufacturer Narrative
The disposable set was reviewed by belmont engineering.It was found the set was leaking from the interface between the tubing and the body of the heat exchanger.Root cause of the leak is consistent with assembly error with not enough solvent being applied to the area of the heat exchanger.All 3-spike disposable sets are 100% leak tested and visually inspected prior to release.No other heat exchanger leaks have been reported from this lot and no patient or user impact was reported.Belmont will continue to monitor trends for this issue.

• 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
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 17568304
• Report Number: 1219702-2023-00041
• Device Sequence Number: 6684208
• Product Code: FRN
• UDI-Device Identifier: 00896128002022
• UDI-Public: 896128002022
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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?: No
• 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: 07/21/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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