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

Catalog Number	903-00006P
Medical Device Problem Codes	Material Separation (1562); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Belmont received mir reference number: (b)(4).Which detailed the following incident.Seal broken around spike, unable to disconnect empty unit or reattach more units.Occurred on two spikes during massive transfusion protocol.There is no indication of any patient harm or impact.
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The ri-2 and disposable involved in the incident have not been returned to belmont medical technologies for evaluation.The user has been contacted to determine if it is possible to obtain the disposable set for investigation.The user will lose the ability to infuse the patient with the affected spikes.Other spikes can be used to infuse the patient and the disposable set can be exchanged to continue infusion.No patient impact was noted as a result of the reported incident.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.The disposable sets are 100% leak tested and visually inspected prior to sale.Without results of the device investigation, no conclusions can be drawn at this time.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Additional Manufacturer Narrative
Belmont followed up with the user facility on feb 12th, feb 22nd, march 7th and march 27th to obtain additional information however none was provided.The disposable set was not provided for investigation.From previous similar complaints, possible causes of this issue include user error due to the user gripping the tubing instead of the spike itself while removing the bag from the spike, or an assembly issue where inconsistent amounts of solvent are applied.A retain sample from the same lot was reviewed, and no issues were identified.As the disposable set was not provided, no device malfunction could be confirmed.Therefore no device malfunction could be verified and the root cause could not be determined.Belmont will continue to monitor this issue moving forward.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Common Device Name: THERMAL INFUSION FLUID WARMER
• 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
• MDR Report Key: 18899558
• Report Number: 1219702-2024-00012
• Device Sequence Number: 9049957
• Product Code: FRN
• UDI-Device Identifier: 00896128002022
• UDI-Public: 0896128002022
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 903-00006P
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown