MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number	FMS 2000
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser, fms2000 involved in the incident has been returned to belmont for investigation; evaluation of the unit is in process.There is insufficient information available at this time to establish a root cause of the reported infusion failure.The fms2000 may not infuse at the set rate if the system is keeping the pressure in the line under the pressure limit.In the event that the flow rate is slowing down or will not go at the set rate, the operator's manual provides the following recommended operator actions: 1) "check and remove kinks or obstructions in the tubing"; 2) "use the appropriate infusion set recommended in the guide, match the infusion set to flow rate and fluid type"; and 3) "increase flow by increasing the pressure limit.Change the pressure limit in calibration/setup to a higher limit (maximum pressure limit is 300 mmhg)".The manufacturing records for this serial number were reviewed and no anomalies were identified.The unit has not been returned to belmont for service or preventive maintenance since it was initially shipped to the customer in 2014.It was reported that another rapid infuser was used to finish the case; there was no harm to the patient.Belmont will perform a thorough investigation of the device and submit a follow-up report accordingly.
Event or Problem Description
The hospital biomed reported that the user was unable to use the rapid infuser, fms 2000 on a patient during a case on (b)(6) 2021 late afternoon.According to the report: a blood bag was connected to the fms machine.After finish priming, 500 ml/min flow rate was selected but the unit was at idle and not proceeding to infuse.There was no error message on the screen.
Additional Manufacturer Narrative
The rapid infuser, fms 2000 involved in the incident was returned to belmont for investigation.Belmont was unable to confirm the reported infusion failure after extensive testing and stress testing at elevated temperatures for 48 hours.The unit was tested in both hardware and infusion modes over a full range of flow rates; the unit performed according to specifications upon receipt.The fms 2000 may not infuse at the set rate if the system is keeping the pressure in the line under the pressure limit.In the event that the flow rate is slowing down or will not go at the set rate, the operator's manual provides the following recommended operator actions: 1) "check and remove kinks or obstructions in the tubing"; 2) "use the appropriate infusion set recommended in the guide, match the infusion set to flow rate and fluid type"; and 3) "increase flow by increasing the pressure limit.Change the pressure limit in calibration/setup to a higher limit (maximum pressure limit is 300 mmhg)".The manufacturing records for this serial number were reviewed and no anomalies were identified.It was reported that another rapid infuser was used to finish the case; there was no harm to the patient.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• 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: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 12284893
• Report Number: 1219702-2021-00107
• Device Sequence Number: 14163152
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• 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,Followup
• Report Date (Section B): 08/05/2021

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: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• 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