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 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

The belmont rapid infuser, ri-2 was returned to belmont for investigation.The reported failure was not easily replicated, however after extensive stress testing the reported touch screen malfunction was confirmed.A definitive root cause could not be established, however upon receipt it was noted that various areas of the housing were cracked and the display panel was damaged, suggesting that the unit had suffered an impact.An impact of this nature may result in damage to internal components, either directly or by allowing fluid to enter the device.Fluid contamination can cause problems with the membrane switch/cpu board interface, however it is not possible to determine whether damage from the impact directly contributed to 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 operator's manual also offers possible conditions and recommended operator actions in the event that the keypad is unresponsive or does not accept input.The manufacturing records for this serial number were reviewed and no anomalies were identified.It was reported that 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.

Event Description

The user facility reported that the touch screen of the rapid infuser, ri-2 intermittently became frozen and unresponsive during a procedure.

• 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: 12215025
• MDR Text Key: 263528786
• Report Number: 1219702-2021-00098
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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