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

Model Number	FMS 2000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit has not been returned to belmont for investigation.The hospital biomed tested the device over the course of several days and was unable to duplicate the customer complaint of smoke or an overheating alarm.We were unable to investigate the disposable set, as it was not returned for evaluation, nor was the lot number of the disposable set provided.When the rapid infuser detects a situation that is compromising effective infusion, the system stops pumping and heating, closes off the line the to the patient, sounds an audible alarm, and displays measures for corrective action.No patient injury was reported.We will continue to follow up with our distributor and the user facility to obtain additional details about the case, as well as the lot number of the disposable set.Without further information, it is difficult to determine what occurred in this incident.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
Our distributor received a complaint from the user facility and relayed the following report: "the user detects smoke odor during infuser.The biomed at the hospital was able to use the unit with no issue but will perform a full pm and functional checklist to confirm any issue." on (b)(6) 2019, our distributor provided the following additional information: "according to a doctor's description after the first few minutes of work the device gave an alert of overheating (100ml / min).A doctor changed the work rate to 500ml / min.And after a few minutes the device smoked.I ran a device at different speeds.For days.And i have not encountered any malfunction or warning.".

• 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: 8511831
• Report Number: 1219702-2019-00021
• Device Sequence Number: 1784146
• Product Code: LGZ
• UDI-Device Identifier: 10896128002036
• UDI-Public: (01)10896128002036
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K032674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: FMS 2000
• Device Catalogue Number: 903-00001A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1