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

Model Number	FMS 2000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation.The manufacturing records for this serial number were reviewed and nothing notable was observed.The user facility was unable to provide the disposable set used in this case, nor was a lot number provided.When the rapid infuser recognizes a situation that is compromising effective infusing, it stops pumping and heating, stops infusing fluid into the patient, displays an alarm message and instructions for corrective measure, and sounds an audible alarm.We have reached out to the user facility for additional information, and to request that the unit be returned for evaluation.Should additional information become available, a supplement report will be submitted accordingly.
Event or Problem Description
The user facility reported that there was an overheat incident after infusing for around 7 hours.The disposable set was discarded.The biomed cleaned up the unit and noticed a crack on the heater disk.

• 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: 8621776
• Report Number: 1219702-2019-00031
• Device Sequence Number: 13548301
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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: 04/17/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1