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	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon follow-up with the user facility, we were able to determine the serial number of the rapid infuser involved.The unit performed according to specification when it was tested by the hospital biomed and was therefore placed back into service.The device has not been returned to belmont for investigation.The user facility was unable to provide a sample or a lot number of the implicated disposable set.A review of the manufacturing records for this serial number indicated nothing notable.The unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2014.The type of infusate used during the procedure was not reported; we have therefore followed up with the user facility to obtain this information, as 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 could 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.It was reported that there was no injury to the patient, nor a delay in treatment.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
Belmont's clinical specialist received a complaint from the user facility and relayed the following report: "during in-service, an anesthesiologist stated that one of the belmont rapid infusers overheated in the past.Anesthesiologist stated he replaced disposable and resumed infusion.Patient was unharmed and did not affect care.The anesthesiologist also mentioned after the case the belmont rapid infuser was sent to biomed.Biomed tested rapid infuser and operated properly.Rapid infuser currently back in service.Disposables discarded and hospital unable to confirm lot numbers or specific device serial number.".

• 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: 8927858
• Report Number: 1219702-2019-00057
• Device Sequence Number: 2048873
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: 903-00001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1