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	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the 3-spike disposable set separated in between the fluid outlet plastic block and the small reservoir.As a result, all spiked fluid products leaked over the ri-2 unit.The patient later died; however, it was confirmed that the patient death was not related to the ri-2 or the disposable set.
Additional Manufacturer Narrative
The internal complaint file (b)(4) has been logged for this incident for traceability.It was reported that during use, the 3-spike disposable set separated in between the fluid outlet plastic block and the small reservoir.As a result, all spiked fluid products leaked over the ri-2 unit.The patient later died; however, 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.Additional information was provided on 26 january, 2026 indicating that the spike had disconnected from the tubing.The operator's manual provides instructions on installing the disposable set and additional recommended operator actions.The manual states "hold the bag spike by the finger grip and spike fluid bag(s), piercing it fully to ensure that the fluid flow freely.Do not push the spike into the bag by the tubing." 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.We checked a retain sample from the same lot, and no issues were identified with this sample.All 3-spike disposable sets are 100% leak tested and visually inspected prior to release.We reviewed the lot history, and no similar confirmed issues were identified.We will continue to monitor these incidents 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: hiba inayath sharief ; 780 boston road; billerica 01821 ; 9786969100
• MDR Report Key: 24405881
• Report Number: 1219702-2026-00008
• Device Sequence Number: 21360668
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: 903-00006P
• Device Lot Number: 20240407
• 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: 01/23/2026
• Initial Report FDA Received Date: 02/20/2026
• 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