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

Model Number	RI-2
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser was returned to belmont for investigation and was tested using our standard operating procedures.We were unable to confirm the customer complaint after extensive testing; the flow rate functioned properly.It was noted that the input temperature probe sensor was dirty; otherwise, the unit performed according to our specifications.The temperature probes should be cleaned before or after each use, according to the service and preventive maintenance schedule provided in the operator's manual.The routine maintenance instructions provided in the operator's manual instructs the user: "keep the probe sensors clean and dry.If they become dirty or wet, clean with a moistened q-tip and dry.Use care not to damage the sensor surface." the user reported that a thin "greasy" film was observed on the display during the procedure, which may have been affecting the touch screen.According to the operator's manual, "the keys that control all system functions are displayed on the screen.The screen is changed each time a function key is pressed.Only keys that are relevant to the desired function are presented.The active key is highlighted.There are three (3) different levels of sensitivity: fast, medium, and slow.The key sensitivity is set at the factory to medium but can be adjusted by the operator in service mode." there was no patient injury reported.The manufacturing records for this serial number were reviewed and nothing notable was observed.We will continue to monitor and trend similar reports of this nature.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The user facility reported that the flow rate was increasing on its own during a case.The user stopped the procedure and found a thin "greasy" film on the display.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10126568
• Report Number: 1219702-2020-00044
• Device Sequence Number: 3406527
• Product Code: LGZ
• UDI-Device Identifier: 00896128002879
• UDI-Public: (01)00896128002879
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2020

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: 903-00037A-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 06/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1