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

Model Number	903-00039A-UK
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency aneurism case the belmont displayed an error code and was removed and replaced by the level 1 to continue case.Patient later died on table but the belmont was not blamed in any way for the outcome of the patient.
Additional Manufacturer Narrative
The internal complaint file # (b)(4) has been logged for this incident for traceability.The ri-2 involved in the incident, serial number (b)(4), was returned to belmont medical technologies for evaluation.The users were unable to provide the specific error/alarm message experienced.The alarm that most likely occurred was one of the ri-2's two heating alarms: a "heating fault" alarm or an "over temperature" alarm.When the ri-2 detects either of these situations, 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 a "heating fault" alarm, the ri-2 displays the following alarm message: "check temperature probes for blockage.Clean windows.Press retry to continue.Service machine if error persists" and in the event of an "over temperature" alarm: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the following conditions may result in a "heating fault" alarm: 1) wet, dirty, or blocked disposable set windows; 2) wet, dirty, or blocked temperature probes; 3) temperature probe failure; 4) heater fault.The following conditions may result in an "over temperature" alarm: 1) over temperature; 2) fluid supply is over the temperature limit, greater than or equal to 42°c; 3) temperature probes are wet, dirty, or blocked; 4)restricted flow or out of fluid.The user reported that the patient later died on table but the belmont was not blamed in any way for the outcome of the patient.Upon receipt at belmont's service department, the service engineers were unable to produce any faults after prolonged testing.The device went through full preventive maintenance testing and no alarms were observed.All tests and inspections passed.The system performed according to specifications.The manufacturing records for this serial number were reviewed and no related anomalies were identified.Since the customer was unable to state the error code, device malfunction could not be verified and the root cause of the reported issue could not be determined.Belmont will continue to monitor for similar reports of this nature and take further action if necessary.

• 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: 14354703
• Report Number: 1219702-2022-00018
• Device Sequence Number: 4155017
• Product Code: FRN
• UDI-Device Identifier: 00896128002817
• UDI-Public: 00896128002817
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Repair,Notification
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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: 903-00039A-UK
• Device Catalogue Number: 403-00412
• 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: 04/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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