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

Model Number RI-2

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

The belmont rapid infuser, ri-2 involved has not been returned to belmont for investigation, therefore the reported system error #215 (real time clock watchdog alarm), unresponsive touch screen, and nonfunctional main power switch cannot be confirmed.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.The ri-2 system contains a watchdog that constantly monitors the flow of information back and forth between the power module and the computer.If the computer detects improper communication, the system stops pumping and heating and displays the error.Fluid contamination can cause problems with the membrane switch/cpu board interface, however without the ability to investigate the device it is not possible to establish a root cause of the reported unresponsive touch screen.The operator's manual cautions the user: "immediately wipe any spills from the device." the service and preventive maintenance schedule outlined in the manual instructs the user to check the unit seals every six months.The troubleshooting guide provided in the operator's manual also offers possible conditions and recommended operator actions in the event that the keypad is unresponsive, or if the user is unable to turn the system off.The reported errors occurred during setup prior to use on a patient; there was no patient injury reported.The manufacturing records for this serial number were reviewed and no anomalies were identified.A review of past complaints indicates that this was an isolated incident.Belmont will continue to monitor and trend similar reports of this nature.

Event Description

The user facility reported that during setup in preparation for a case, the rapid infuser, ri-2 experienced the following problems: exhibited a system error #215; touch screen became unresponsive; was unable to power off with the main power switch.

• 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 ; 9783307637
• MDR Report Key: 12221562
• MDR Text Key: 263405026
• Report Number: 1219702-2021-00100
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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