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

Model Number RI-2

Device Problems Erratic or Intermittent Display (1182); Tactile Prompts/Feedback (4022)

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

Event Date 10/11/2020

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser was returned to belmont for investigation and underwent testing according to our standard operating procedures, and stress testing at elevated temperatures for 48 hours.We were unable to duplicate the customer complaint that the flow rate was changing on its own.The display and membrane switch were found to be functioning properly; the unit performed according to specification.However, upon reviewing a video provided by the user facility we were able to confirm that the touchpad was not always activated by the user's touch, therefore, we replaced the gathering board and the membrane switch in the system as a precaution.Fluid contamination can cause problems with the membrane switch/cpu board interface, which may resolve itself once the fluid has dried.The operator's manual cautions the user: "immediately wipe any spills from the device." the service and preventive maintenance schedule outlined in the manual also instructs the user to check the unit seals every six months.The manufacturing and service records for this serial number were reviewed and no anomalies were identified.Without the ability to reproduce the reported problem, a root cause could not be determined.No patient injury was reported.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.

Event Description

The biomed at the hospital reported that within five minutes of infusing at 100 ml/min during a case in the or, the flow rate changed to 500 ml/min without anyone touching the screen.

• 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: 10826607
• MDR Text Key: 216184793
• Report Number: 1219702-2020-00097
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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