MAUDE Adverse Event Report: 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 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation on 2/5/2021; evaluation of the unit is in process.Fluid contamination can cause problems with the membrane switch/cpu board interface, however without results of the investigation a root cause cannot be established.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.It was reported that the unit was restarted and subsequently became functional again; no patient injury was reported.A follow-up report will be submitted upon completion of the investigation.

Event Description

The user facility reported that during a case the rapid infuser, ri-2 touch screen started to increase the flow rate on its own and the up/down arrow key did not respond when pressed.

Manufacturer Narrative

The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation.We were unable to duplicate the reported touch screen issues.The functionality of both the display and the membrane switch were verified, and the power driver module and all cables in the system were checked for proper connections; the unit performed according to specification.Fluid contamination can cause problems with the membrane switch/cpu board interface, however without the ability to duplicate the reported problem a root cause cannot be established.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.It was reported that the unit was restarted and subsequently became functional again; no patient injury was reported.Belmont will continue to monitor and trend similar reports of this nature.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• MDR Report Key: 11325345
• MDR Text Key: 231977639
• Report Number: 1219702-2021-00022
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: (01)10896128002630
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 02/05/2021
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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