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

Model Number RI-2

Device Problem Image Display Error/Artifact (1304)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 has not been returned to belmont for investigation.The user facility was unable to provide the specific serial number of the ri-2 involved.Following receipt of the hospital's report, belmont's sales representative went to the hospital and conducted a field test on the functionality of the four ri-2 units in the emergency department (serial numbers (b)(4)); all four units performed according to specification.Without the ability to investigate the unit, we are unable to confirm the report that the prime and infuse screens became overlaid upon one another.A review of the manufacturing records for all four serial numbers indicated that one unit (serial number (b)(4)) was returned to belmont in december 2020 for a non-functional touch screen, which was traced to damage caused by saline contamination.Fluid contamination can cause problems with the membrane switch/cpu board interface and contribute to touch screen issues which may resolve once the fluid has dried.The operator's manual provides instructions for routine maintenance to prevent damage to the membrane switch and cpu board interface caused by fluid contamination.The service and preventive maintenance schedule outlined in the manual instructs the user to check the unit seals every six months and cautions the user: "immediately wipe any spills from the device." the troubleshooting guide in the operator's manual also provides possible conditions and recommended operator actions in the event that the keypad is unresponsive or does not accept input.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont's sales representative relayed the following report about a rapid infuser, ri-2 from the physician: "i was helping them with it the screen froze.The prime screen and the infuse screen were overlaid upon one and other.I cleared it by turning the machine on and off." the user facility was unable to provide the serial number of the ri-2 involved.

• 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
• MDR Report Key: 12456421
• MDR Text Key: 280762935
• Report Number: 1219702-2021-00118
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• 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
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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?: Yes
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1