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

Model Number RI-2

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 has been returned to belmont for investigation; evaluation of the unit is in process.Review of the video provided by the user facility indicates that the display was flickering as reported.Without results of the investigation, a root cause cannot be established.As fluid contamination can cause issues with the membrane switch/cpu board interface, 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, and provides the following instructions: "inspect the seal around the unit to make certain it is in good condition.Check also the seal around the touch screen and ceramic disks.Use dow corning 732 multipurpose rtv sealant or equivalent if needed to maintain fluid resistance." 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.A follow-up report will be submitted upon completion of the investigation.

Event Description

The user facility reported that the rapid infuser, ri-2 display was flickering during a case.

• 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: 11750033
• MDR Text Key: 252699261
• Report Number: 1219702-2021-00063
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• 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: 04/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: No
• 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