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

Model Number	RI-2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser involved in this incident has not been returned to belmont for investigation and we are therefore unable to confirm the reported system error #215 (real time clock watchdog alarm).When the rapid infuser detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.The ri-2 system contains a watchdog that constantly monitors the flow of information back and forth between the power module and the computer.If the computer detects improper communication, the system stops pumping and heating and displays the error.No patient injury was reported.The manufacturing and service records for this serial number were reviewed and it was noted that this device was previously returned to belmont for the same issue in may 2019.The problem was traced to an improper software update by the distributor.The distributor was made aware of the improper maintenance and additional instructions were provided.Belmont has requested that this unit be returned to the manufacturer for further investigation.Additional training will be provided to the distributor if necessary.No trend has been identified for this type of issue.Should additional relevant information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's distributor reported that a belmont rapid infuser, ri-2 was exhibiting intermittent system error #215 alarms during use.The time and date were not displaying properly.

• 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: 11142782
• Report Number: 1219702-2021-00008
• Device Sequence Number: 4051278
• Product Code: LGZ
• UDI-Device Identifier: 00896128002794
• UDI-Public: (01)00896128002794
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: 903-00037A-SW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1