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

Model Number	903-00006P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The ed staff reported a tubing had torn and blood ran all over the unit.They were able to wipe it all down and it is also due for a (b)(6) 2025 pm.
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The disposable involved in this incident was returned to belmont for investgation on feb 18th, 2025.Although it is alleged that patient was injured, the user facility confirmed that the device did not caused or contribute to patient injury.The disposble set can be exchanged to continue infusion.Other disposable can be used 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.The disposable set involved was returned and was visually inspected by belmont engineering.Through visual inspection, it could be confirmed there was a fracture at the bottom of the white connector which lead to the reported leaking of blood.Due to contamination of the disposable set, a thorough investigation could not be performed.And a precise root cause of the fracture could not be identified.All disposable sets are 100% leak tested and 100% visually inspected prior to release.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

• Brand Name: 3-SPIKE DISPOSABLE SET (1 PIECE)
• 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: 21537284
• Report Number: 1219702-2025-00017
• Device Sequence Number: 12546129
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 896128002022
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 903-00006P
• Device Lot Number: 2022-04 01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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