MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET; THERMAL INFUSION FLUID WARMER

Model Number	903-00006
Medical Device Problem Codes	Mechanical Problem (1384); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Belmont received mir report on 1/7/2025.Detailing the following.Belmont rapid infuser giving set used to infuse approximately 40 units of blood products, towards the end of use the giving set came apart at two of the three bag spikes on the infusion line.Belmont has received confirmation that there was no impact / harm to the patient.
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 has not been returned to belmont medical technologies for evaluation.The user facility confirmed that the disposable set involved in this incident was discarded therefore could not be sent for review.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 cited disposable set was discarded and could not be sent for investigation.An investigation into the lot history for lot 20240213 was performed.And the retain sample was inspected.No issues were noted on the retain sample and no other similar complaints have been received for this lot.All disposable set are 100% leak tested and visually inspected prior to release.The user confirmed that there was no patient harm as a result of the alleged incident.The root cause of the alleged incident could not be determined.Testing of a device from the same lot was conducted and no issues were found.No device malfunction could be verified, and the root cause of the alleged incident could not be determined.No patient harm was confirmed by the user.Belmont will continue to monitor this issue moving forward.

• Brand Name: 3-SPIKE DISPOSABLE SET
• 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: 21322631
• Report Number: 1219702-2025-00008
• Device Sequence Number: 15433313
• Product Code: LGZ
• UDI-Device Identifier: 10896128002029
• UDI-Public: 10896128002029
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K242735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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 Model Number: 903-00006
• Device Lot Number: 20240213
• 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: 01/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown