MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET (1 PIECE); WARMER, THERMAL, INFUSION FLUID

Model Number	903-00006P
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The medwatch #mw5163140 stated the following: belmont rapid infuser had blood clots in and around the filter and through the entire line.
Additional Manufacturer Narrative
The internal complaint file # (b)(4) has been logged for this incident for traceability.The disposable involved in this incident was not returned to belmont for evaluation.Per medwatch user facility report #mw5163140, the date of event is november 27th, 2024, but the user facility did not inform belmont about this incident when it actually occured.We became aware of this incident on january 13th, 2025, after reviewing the maude database therefore, reporting this now.Although the user facility report states patient injured/required intervention, it is not clear if device contributed to injury or what exactly happened to the patient.The medwatch report did not have any information of the user facility, contact information or serial number of the device involved.The disposable set involved in this incident was not provided to belmont for investigation.Therefore, a thorough investigation of the disposable could not be carried out.No investigation could be carried out into the device and lot history.No other additional information was available from the event.All 3- spike sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.No device malfunction could be verified, and the root cause could not be determined.The complaint file will be reopened in the event additional information become available.We will continue to monitor this type of incident closely and take further corrective and preventive action if required.

• Brand Name: 3-SPIKE DISPOSABLE SET (1 PIECE)
• Common Device Name: WARMER, 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 21370763
• Report Number: 1219702-2025-00010
• Device Sequence Number: 8564469
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (Y/N): N
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 903-00006P
• 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: 01/13/2025
• Initial Report FDA Received Date: 02/12/2025
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White