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

Catalog Number	903-0000
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file (b)(4) has been logged for this incident for traceability.The device involved in the incident will not be returned to belmont for investigation since it was identified as end of life.The disposable set involved in this incident was discarded.Although the patient involved in the incident expired, the user facility confirmed that mtp was a lifesaving attempt and the patient was very ill beforehand.The reported issue did not impact the outcome of the patient.The device involved in the incident will not be returned to belmont for investigation since it was identified as end of life.Without the ability to inspect the device ior the disposable it is not possible to reach a definitive root cause.There is no indication of the use of contraindicated fluids.Certain infusates such as calcium, and platelets 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 will become overheated and cause an over temperature/overheating issue.The potential cause of smoke in this incident could be associated with overheating of the device.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." belmont has sent an 'end of life' letter to this hospital and requested them to replace the end of life devices.There is a possibility of user error in this incident, belmont contacted the user on 08/23, 09/04, and 09/19 to arrange re-training but received no response.Belmont is closing this complaint due to lack of response from the user.Should a response be subsequently recieved a follow up report shall be submitted.
Event or Problem Description
The biomed reported that during a procedure, the nurse noticed electrical burning smell and smoke coming from fms 2000.The device also had an error message on the screen.Although the patient involved in the incident expired, the user facility confirmed that mtp was a lifesaving attempt and the patient was very ill beforehand.The malfunctioning of the machine did not impact the outcome of the patient.

• 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: 17803740
• Report Number: 1219702-2023-00047
• Device Sequence Number: 15240568
• Product Code: FRN
• UDI-Device Identifier: 10896128002012
• UDI-Public: 10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

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: 903-0000
• 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: 08/22/2023
• Initial Report FDA Received Date: 09/22/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown