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

Model Number	FMS 2000
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser, fms 2000 was returned to belmont for investigation on 12/8/2021; evaluation of the unit is in process.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.In the event of an "over temperature" alarm, the rapid infuser displays the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.Certain infusates are contraindicated and may lead to clot formation inside the heat exhcanger, which can block blood flow and result in an "over temperature" alarm.The clinicians reported that only prbcs were infused.There was no report of damage to the disposable set.It is unclear at this time what caused the reported "overheat." it was reported that the patient death was not related to the device or due to the reported overheat.Belmont has followed up with the hospital to determine the status of the disposable set, as well as the status of the patient prior to the incident.As of the date of this report no additional information has been received.The manufacturing records for this serial number were reviewed and no anomalies were identified.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported that the rapid infuser, fms 2000 "overheated." the patient deceased, however it was reported that the death was not due to the system or to the reported overheat.

• 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
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 13031937
• Report Number: 1219702-2021-00130
• Device Sequence Number: 4423336
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown