MAUDE Adverse Event Report: Belmont Medical Technologies Rapid Infuser RI-2, 120V, 1000ml/min; Thermal Infusion Fluid

Model Number	903-00037
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Following an incident involving the patient sustaining a gun shot wound to the abdomen with an exit wound through the back.The patient was found by acp on scene with police and had seals placed to the abdomen and back.The patient was placed in the ambulance, assessed and transported.The patient arrived as a code trauma and an mhp was activated.The patient was diverted to the or due to hemodynamic instability for a stat damage control laparotomy procedure.During priming of the infuser - multiple air alarms were encountered and the device was not able to be used to the time sensitive nature of the mhp.In the end 2 cartridge systems were wasted and resuscitation was done manually with 5-6 hand pumped pressure bags and multiple staff supporting.The patient was stabilized in the or and transferred to a level 1 trauma center for further management.
Additional Manufacturer Narrative
The internal complaint file #cmp-(b)(4) has been logged for this incident for traceability.The ri-2 involved in this incident has not yet returned to our distributor for investigation.It was reported that following an incident involving the patient sustaining a gun shot wound to the abdomen with an exit wound through the back.The patient was found by acp on scene with police and had seals placed to the abdomen and back.The patient was placed in the ambulance, assessed and transported.The patient arrived as a code trauma and an mhp was activated.The patient was diverted to the or due to hemodynamic instability for a stat damage control laparotomy procedure.During priming of the infuser - multiple air alarms were encountered and the device was not able to be used to the time sensitive nature of the mhp.In the end 2 cartridge systems were wasted and resuscitation was done manually with 5-6 hand pumped pressure bags and multiple staff supporting.The patient was stabilized in the or and transferred to a level 1 trauma center for further management.A facility report was filed; therefore, belmont is filing a report as per procedure.Belmont contacted our distributor galen medical on (b)(6) to inform them of this alleged incident.Galen had not previously been aware of the incident and they confirmed on (b)(6) that they had contacted the user and requested the device to be returned for investigation.The user confirmed to galen that there was no impact to the patient as a result of the alleged incident.Without results of the device investigation, no conclusions can be drawn at this time.The investigation is ongoing and no root cause can be determined at this time.A follow-up report will be submitted once the investigation is complete.

• Brand Name: Rapid Infuser RI-2, 120V, 1000ml/min
• Common Device Name: 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: garet tierney ; 780 boston road; billerica, MA 01821
• MDR Report Key: 50458090
• Report Number: 1219702-2026-00026
• Device Sequence Number: 18657768
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K242735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 903-00037
• 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: Not provided
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown