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	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged incident was not reported to belmont or our importer galen medical in canada.Belmont became aware of the incident via a health canada user facility report received on march 27th, 2024.The internal complaint file #(b)(4) has been logged for this incident for traceability on the day it was received and therefore submitting this now.The ri-2 and disposable involved in the incident have not been returned to belmont medical technologies for evaluation.The user facility confirmed april 17th, that there is no patient injury associated with this event and lot number is not available.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.A spike disconnect is visibly obvious to the user while interacting with the set.Other spikes can be used to continue infusion.In addition, the disposable set can be exchanged to continue infusion.No patient impact was noted as a result of the reported incident.Belmont requested additional information from the distributor but, have have not received any details to date.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.
Event or Problem Description
The user facility reported that at bay a3 using belmont rapid infuser to administer blood rapidly to a patient who was in critical condition, had an alarm to re prime, which was done, then during transfusion it appears a plastic peg popped out, and blood sprayed all over, and unit no longer functioning, staff had to quickly prime another unit and get another unit of blood to give to this patient who was in critical condition, needing blood quickly, patient unable to get 1st unit, as it sprayed all over.

• 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 MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 19192019
• Report Number: 1219702-2024-00018
• Device Sequence Number: 18047477
• Product Code: FRN
• UDI-Device Identifier: 00896128002022
• UDI-Public: 0896128002022
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: 03/27/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown