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

Model Number	903-00006
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file # (b)(4) has been logged for this incident for traceability.The disposable set involved in this incident was discarded therefore was not available for investigation.It was reported that at the end of the procedure, while removing the disposable set, staff observed blood staining around the right side of the heat exchanger.The patient was transferred to another hospital for different medical care and later expired.The user facility confirmed that the device did not contribute to the patient's death.As per belmont's procedure, a report is being submitted.A leak would be obvious to the user while interacting with the device.The disposable set can be exchanged to continue infusion.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.There was no report that the blood stains impacted the functionality of the device.The rapid infuser involved in the incident was functionally tested onsite and passed with no issues.The disposable set used during the procedure was discarded and was not available for investigation.The lot number of the disposable set involved was unknown.However, an image of a disposable set in stock with lot # 20250712 was provided.A review of the lot history for this lot identified no other related complaints.No device malfunction could be verified, and the root cause of the reported incident could not be determined.We will continue to monitor these incidents closely and take further corrective and preventive action if required.
Event or Problem Description
It was reported that at the end of the procedure, while removing the disposable set, staff observed blood staining around the right side of the heat exchanger.The patient was transferred to another hospital for a different medical care and later expired.The patient death was unrelated to the ri-2.The biomed will clean the unit and perform functional testing; results will be provided when available.

• Brand Name: 3-SPIKE DISPOSABLE SET
• Common Device Name: THERMAL INFUSION FLUID
• 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: hiba inayath sharief ; 780 boston road; billerica, MA 01821
• MDR Report Key: 24188418
• Report Number: 1219702-2026-00001
• Device Sequence Number: 21273875
• Product Code: LGZ
• UDI-Device Identifier: 10896128002029
• UDI-Public: 10896128002029
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/27/2026
• 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