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

Model Number FMS 2000

Device Problem Complete Loss of Power (4015)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, belmont medical technologies became aware of the following incident reported to danish medicines agency: "belmont is turned on before priming as there has been problems with it before, when priming is started goes out belmont spontaneously.The plug is in this straight contact - both on the outlet and in the machine.Attempts have been made to switch socket without power, also on and off on the machine - it is completely black with no response.You stopped treatment due to hopelessness related to the many injuries.Belmont was not decisive for the present death.Current belmont has been for annual inspection at company and our medicomechanical dept.Approved therefrom.Immediately is found 2 possible errors (just preliminary message then uth / lms runs independently): a possible defect battery (company returns) · fault wiring contact in belmont as someone (not the company) has applied liquid sanitary silicone around the silicone cap by the cord.The cord is born with silicone cap to prevent fluid / blood from escaping comes in and to ensure cleaning - it's right now unclear who has applied this liquid silicone (the department of medicine has done this.)".

Manufacturer Narrative

During investigation, belmont medical technologies followed up with the distributor, fischer devices, and became aware that the device in question is a rapid infuser, fms2000, serial number (b)(4).The distributor evaluated the rapid infuser and noted that silicone had been applied around the plug in the machine, which prevented the cord from staying in place.It was also noted that the batteries were only able to hold power for a short time and needed to be replaced.This would cause the unit to shut down if the power cord was not properly in place, as there is no battery power to keep the machine running.It is important to note that battery backup of the rapid infuser only allows for mobile transport of the patient and system.During battery operation, pump operation and safety monitoring remain active, but fluid warming is disabled.Flow rate during battery operation is limited to 50 ml/min.It was reported that after removing the silicone from the plug and replacing the batteries, the distributor was able to run the machine for 48 hours without any issue.Belmont also followed up with the hospital directly, and the distributor's evaluation of the device was confirmed.The hospital confirmed that the batteries were replaced and that the distributor was surprised to find silicone applied around the cord; it was reported that the silicone was applied by the department of medicine at the hospital.It was also reported that the device did not contribute to patient death.The manufacturing records for this serial number were reviewed and no anomalies were identified.The conclusion reached is that the reported power loss is due to modification of the device by adding silicone around the power cord, which prevented the cord from being fully engaged.Due to the battery's inability to hold charge, the system shut down.Modification of the device is not allowed, as it can affect product performance.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: 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 ; 9786969137
• MDR Report Key: 13637995
• MDR Text Key: 287902052
• Report Number: 1219702-2022-00010
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002371
• UDI-Public: (01)10896128002371
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K091855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FMS 2000
• Device Catalogue Number: 903-00024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1