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

Model Number	RI-2
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the unit was cleaned, and subsequently tested by the medical technical engineer at the hospital, who was unable to reproduce the problem.The rapid infuser was returned to belmont for investigation and was tested using our standard operating procedures.We were also unable to confirm the report that the bolus setting was changing spontaneously.The display, membrane switch, and bolus setting were all evaluated and found to be functioning properly; the unit performed according to specification.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.Without the ability to reproduce the reported problem, a root cause could not be determined.It was reported that there was no injury to the patient.A review of past complaints indicates that no trend has been identified for this type of issue.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 or Problem Description
Belmont's distributor received a complaint from the user facility that the bolus setting of a rapid infuser, ri-2 was changing spontaneously during a case.There was no injury to the patient as a result of the incident.The medical technical engineer at the hospital subsequently tested the ri-2, and was unable to reproduce the problem.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 10646266
• Report Number: 1219702-2020-00082
• Device Sequence Number: 2555365
• Product Code: LGZ
• UDI-Device Identifier: 20896128002774
• UDI-Public: (01)20896128002774
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039A-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1