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

Model Number	903-00006
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The disposable involved in this incident was not returned to belmont for investigation.The incident was initially reported to belmont by the user facility on (b)(6) 2026.It was reported that the icu team responded to a rapid response event to initiate a massive transfusion protocol (mtp) on a medical-surgical unit.During priming of the belmont tubing set, a crack was identified at the white connector proximal to the drip chamber, resulting in fluid leakage.The disposable set was replaced to complete the transfusion.Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, belmont was informed on (b)(6) 2026 a medsun report #(b)(4) was filed for this event.Per belmonts policy, an mdr is being submitted as the event involved a user facility report.The operator's manual provides instructions on installing the disposable set and additional recommended operator actions.The user is instructed to "prime the main system with solutions compatible with blood products" prior to use.Any leak from a connector would be noticeable prior to use with a patient.The disposable set was discarded and could not be returned for investigation, therefore we were unable to verify the reported issue.However, the customer provided the lot number (lot #20240910).Belmont field action #(b)(4), issued on (b)(6) 2025, applies to certain affected lots, including the reported lot.The provided lot number confirms the disposable set is within the scope of the field action.Records confirm that the customer acknowledged the field action on (b)(6) 2025.The customer was advised to review inventory to ensure that no affected disposable sets with cracked quick connectors remain in use.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 the icu team responded to a rapid response event to initiate a massive transfusion protocol (mtp) on a medical-surgical unit.During priming of the belmont tubing set, a crack was identified at the white connector proximal to the drip chamber, resulting in fluid leakage.The disposable set was replaced to complete the transfusion.

• Brand Name: 3-SPIKE DISPOSABLE SET
• 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, MA 01821 ; 9786969100
• MDR Report Key: 24966893
• Report Number: 1219702-2026-00017
• Device Sequence Number: 18766004
• Product Code: LGZ
• UDI-Device Identifier: 10896128002029
• UDI-Public: 10896128002029
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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
• Device Model Number: 903-00006
• Device Lot Number: 20240910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/23/2026
• 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