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

Model Number	FMS 2000
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomed ran the unit for a few hours in the lab and was unable to duplicate the complaint that the unit was losing power.The rapid infuser was subsequently returned to belmont for investigation and we were also unable to confirm the customer complaint.The unit performed according to our specifications upon receipt.We reached out to the user facility for additional information and they were unable to provide any additional information about the case.The hospital biomed stated that they believed the circuit breaker on the switch was flipping off, but that failure was not observed during their own test.The manufacturing and service records for this serial number were reviewed.The unit was returned in 2011 to investigate a complaint that the unit had "no power" which was attributed to two cracked solder joints on the cpu board upon evaluation.This is the only time the unit has been returned for service since it was shipped to the customer in 2008.It was reported that the patient was not injured.We will continue to monitor and trend similar reports of this nature.
Event or Problem Description
The user facility reported that the rapid infuser lost power during a case.Another unit was brought in to finish the procedure and the patient was not harmed.The biomed was unable to duplicate the failure after running the unit nonstop for a few hours in the lab.

• 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: 8279455
• Report Number: 1219702-2019-00006
• Device Sequence Number: 16724893
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032674
• 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): 01/25/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1