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

Model Number	RI-2
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser involved in this incident was returned to belmont for investigation on 12/23/2020.Evaluation of the unit is in process.It was reported that there were additional devices plugged into the same power line with the rapid infuser, which is not in accordance with belmont's instructions for use.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle." it was reported that the incident occurred at power-up when the device was being set up for a procedure.No patient was affected.Belmont will evaluate the device and provide a follow-up report upon completion of the investigation.
Event or Problem Description
Belmont's distributor received a report involving a belmont rapid infuser, ri-2 from the clinical engineer at the hospital and relayed the following report: "caregiver were setting up or for an emergency case and they noticed that power line in which device was connected was tripped.There were other devices in same line and complete line was tripped.This device was isolated and found to be cause for tripping in mcb and one of the caregiver mentioned to hear a noise from the device before tripping.No patient was affected but caused delay in the procedure during preparation.Inspected other devices in same line and they found to be working good.".
Additional Manufacturer Narrative
The rapid infuser involved in this incident was returned to belmont for investigation and was tested according to our standard operating procedures.Upon receipt it was determined that four transistors on the driver b board were shorted and damaged, which caused the circuit breaker on the system to trip.It was reported that there were additional devices plugged into the same power line with the rapid infuser, which is not in accordance with belmont's instructions for use.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle." it was reported that the incident occurred at power-up when the device was being set up for a procedure.No patient was affected.Should additional information become available, a supplemental report will be provided.

• 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: 11158770
• Report Number: 1219702-2021-00009
• Device Sequence Number: 10974488
• Product Code: LGZ
• UDI-Device Identifier: 10896128002753
• UDI-Public: (01)10896128002753
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: RI-2
• Device Catalogue Number: 903-00037A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/13/2020
• Supplement Date Received by Manufacturer: 12/13/2020
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1