MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER, RI-2; PUMP INFUSION

Catalog Number	903-00039
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Emits Odor (1425); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file (b)(4) has been logged for this incident for traceability.The ri-2 involved in this incident was not returned to belmont for evaluation and the user confirmed that the disposable set involved in this incident was discarded therefore could not be sent for review.The medwatch has date of event as 25th may whereas, we were informed as 27th may by the biomed.Incident was initially reported to belmont by the biomed on may 30th, 2024 that the unit stopped working during a case with electrical malfunction message with no details of the exact error code or description.The failure occurred during a case after 32 units of blood were infused with no report of a patient harm and did not include any claim of a burning smell being present from the device.User detailed 'fine for 31 units, happened at end stage, just finished case.Center (heat exchanger) melted and blood dripped on floor".Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, we received medwatch report (b)(4) on july 23rd, 2024, which per our procedure requires us to submit a report now.Upon subsequent investigation, after receiving the medwatch, it was confirmed by the user facility that platelets were infused during this event using the rapid infuser.The operator's manual contains information on contraindicated fluids and clearly states that "platelets are contraindicated for use with the system and should not be used", as they can compromise the anticoagulants in citrated blood and promote clotting, which can lead to clot formation inside the heat exchanger and block blood flow.If this occurs, the stainless steel rings inside the heat exchanger may become overheated.Belmont was unable to confirm if the device provided an overheat alarm.If an alarm is provided, 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.Other methods can be used to infuse the patient.The user facility stated that there was a leak and provided a picture of the compromised disposable, however the disposable in question was discarded.The disposable set can be exchanged to continue infusion.There is no report of any patient harm associated with this incident.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.Evaluation: the device was requested for investigation; however, it was not provided as the ri2 device was tested by the user onsite with no failure.It was confirmed that the disposable set involved was discarded and could not be provided for investigation.The lot number of the disposable set was unknown, therefore a thorough investigation into the lot could not be performed.A photograph was provided of the disposable which appears to show deformation at the heat exchanger.Additional information was provided that platelets were infused into the device which is not a compatible solution.Root cause of the reported issue is consistent with user error from infusing contraindicated fluids into the device.The device history for the ri-2 unit was reviewed and no other issues were identified.In order to avoid similar incidents in future, belmont conducted refresher training for clinical staff at the user facility on august 14th including a review of compatible solutions with the device and proper use of device per our specifications.
Event or Problem Description
On july 23rd, 2024, belmont received medwatch reference number (b)(4) detailing an incident that occured on may 25th, 2024.The medwatch report stated that during mtp (massive transfusion protocol) the belmont heating element/filter burned through and started leaking blood onto the floor.This was at or about blood product number 32.There was a blackened area to the ring.Electrical burning smell was also present.The belmont rapid transfuser was found to have no malfunction.Tubing malfunction suspected.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Common Device Name: PUMP INFUSION
• 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: 20036741
• Report Number: 1219702-2024-00037
• Device Sequence Number: 12389203
• Product Code: FRN
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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 Catalogue Number: 903-00039
• 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: 05/30/2024
• Initial Report FDA Received Date: 08/22/2024
• 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