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

Model Number	RI-2
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser was returned for investigation and was tested using our standard operating procedures.We were unable to confirm the customer complaint that the unit exhibited an "over temperature" alarm.However, upon receipt, it was noted that the input temperature probe was dirty.This could cause an "over temperature" alarm if the temperature probes are not cleaned according to the instructions provided in the operator's manual, as it could cause the system to misread the input fluid temperature.The operator's manual states: "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 disposable set was not returned for evaluation, nor was a lot number available.We will continue to reach out to the user facility to try to determine the lot number of the disposable set, as well as the type of infusate used during the procedure.Certain infusates are contraindicated and may lead to clot formation inside the heat exchanger, which can block blood flow and result in an "over temperature" alarm.This alarm will cause the system to shut down, as it is designed to do.When the rapid infuser recognizes a situation that may compromise safe and effective infusion, 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.Belmont technical support will offer to assist with additional training.No patient injury was reported.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Our distributor reported that the rapid infuser exhibited an "over temperature" alarm.

• 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: 9101151
• Report Number: 1219702-2019-00065
• Device Sequence Number: 19508100
• Product Code: LGZ
• UDI-Device Identifier: 40896128002754
• UDI-Public: (01)40896128002754
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1