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

Model Number RI-2

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 was returned to belmont for investigation and underwent testing according to our standard operating procedures, as well as stress testing at elevated temperatures for 48 hours.We were unable to duplicate the customer complaint that the screen was freezing.The functionality of the display, membrane switch, and cpu board were verified, and all cables in the system were checked for proper connections; the unit performed according to specification and passed all inspection requirements.Fluid contamination can cause problems with the membrane switch which may resolve once the fluid has dried, however belmont has replaced the membrane switch as a precaution.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.Without the ability to reproduce the reported problem, a root cause cannot be established.The manufacturing records for this serial number were reviewed and no anomalies were identified.It was reported that another rapid infuser was used to complete the case; there was no injury to the patient.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 anesthesia tech at the user facility reported that the screen on the rapid infuser, ri-2 was freezing during a case.Another ri-2 was used to complete the case without further issue.

• 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: 11478616
• MDR Text Key: 249079793
• Report Number: 1219702-2021-00042
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: (01)10896128002630
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2021
• 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: 903-00037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• 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