MAUDE Adverse Event Report: Belmont Medicat Technologies 3-Spike Disposable Set; Warmer, Thermal, Infusion Fluid

Model Number	903-00006
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user facility that during a liver transplant procedure, the belmont rapid infuser ri-2 displayed system error #102.The error message instructed the user to discard the disposable and blood, restart the system with a new disposable, and service the device if the error persisted.The unit was also reported to be unusually hot to the touch.
Additional Manufacturer Narrative
The internal complaint file#: (b)(4) has been logged for this incident for traceability.The incident was initially reported to belmont by the user facility on july 23, 2026.It was reported by the user facility that during a liver transplant procedure, the belmont rapid infuser ri-2 displayed system error #102.The error message instructed the user to discard the disposable and blood, restart the system with a new disposable, and service the device if the error persisted.The unit was also reported to be unusually hot to the touch.Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, belmont received a user facility report on august 24, 2026, therefore belmont will file a report.When the rapid infuser detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.In the event of an "over temperature" alarm, the rapid infuser exhibits the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the user will lose the ability to infuse the patient during the event.A 102 alarm is generated to alert the user of the condition of the device.The operator manual states the following: "check disposable set and flow path for occlusions.Make certain the windows on the disposable set and the ir probes are clean and dry.Clean surfaces with moistened soft cloth if necessary.Dry off surfaces before continuing.Make sure bag clamps are open and flow is unimpeded.Make sure that the filter is not clogged.Add more fluid if fluid out.Clamp off the bag spikes and patient line and remove disposable.Power off and restart system with a new disposable.Service machine if the problem persists." a message appears on the screen to discard the disposable and blood and to restart the system with a new disposable.Infusion of the patient can be continued by other means if the error persists.The disposable set involved in the incident was reviewed by belmont engineering.After visual inspection, there was no evidence of any clotting or deformation to the plastic.The sample was run for an extended period of time under recirculation with a known working rapid infuser.The system error 102 could not be confirmed and it was found the temperature values were normal.The lot number of the disposable set involved was unknown.A review into the lot history could not be carried out.All 3-spike disposable sets are 100% leak tested and visually inspected prior to release.The rapid infuser involved in the incident (sn: (b)(6) has been tested as is back in use with no further reported issues.The device history was reviewed, and no other issues were identified.No device malfunction could be verified, and the root cause of the reported system error 102 could not be determined.Belmont will continue to monitor these incidents closely and take further corrective and preventive action if required.

• Brand Name: 3-Spike Disposable Set
• Common Device Name: Warmer, Thermal, Infusion Fluid
• Manufacturer (Section D): Belmont Medicat Technologies; 780 boston road; billerica MA 01821
• Manufacturer (Section G): Belmont Medicat Technologies; 780 boston road; billerica MA 01821
• Manufacturer Contact: hiba inayath sharief ; 780 boston road; billerica, MA 01821 ; +1(978)696-9100
• MDR Report Key: 50867025
• Report Number: 1219702-2026-00028
• Device Sequence Number: 9223997
• Product Code: LGZ
• UDI-Device Identifier: 10896128002029
• UDI-Public: 10896128002029
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K242735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 09/23/2026
• 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