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

Catalog Number	903-00006P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a massive transfusion event using belmont tubing, one of the spikes from the y-site broke off into the bag of blood when the bag was spiked.There was no patient harm associated with this incident.
Additional Manufacturer Narrative
The user facility did not inform belmont about this incident when it occurred on august 7th, 2023, belmont became aware of this incident after receiving medwatch report #mw3400690000-2023-8012 on december 18th, 2023.Internal complaint file # (b)(4) has been logged for this incident for traceability.The ri-2 involved in the incident has not been returned to belmont medical technologies for evaluation.The disposable set was discarded therefore could not be sent for review.The broken spike is obvious to the user while interacting with the device.The disposble set can be exchanged to continue infusion.Other spike ports can also be used 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.The risk manager (initial reporter from the user facility) confirmed january 12th, that there are no images or lot number available.Since the lot number was not available, a thorough investigation of the affected lot could not be performed.There were no other complaints received for spike disconnects from other user facilities where the product was distributed based on the lots sold to the customer.The available retain samples from these lots were tested and no issues were identified.As the set was not returned, a precise root cause could not be determined.Therefore no device malfunction could be verified and the root cause could not be determined.We 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 MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 18515262
• Report Number: 1219702-2024-00003
• Device Sequence Number: 18085890
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 896128002022
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 01/15/2024

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: 903-00006P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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