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

Model Number	RI-2
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser, ri-2 was tested by belmont medical technologies service department in the uk and the fault was replicated.Follow up with the user facility revealed that the ri-2 device was plugged into a 20 amp ceiling pendant system along with the following devices: anaesthetic machine, cell saver, pc, and syringe pump.This 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." the manufacturing records for this serial number were reviewed and no anomalies were identified.It was reported that another belmont rapid infuser was used to complete the case without further issue, no patient injury was noted.The ri-2 has been returned to belmont's manufacturing headquarters in the us for further testing.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Belmont medical technologies received a report from the user facility that the power went off in the or while the belmont rapid infuser, ri-2 was in use.
Additional Manufacturer Narrative
The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation.Evaluation of the device revealed that the driver board was shorted and damaged, which damaged four power transistors and caused the system circuit breaker to trip.In addition, it was noted that the display was damaged and the back of the housing was dented, suggesting that the unit suffered an impact.An impact of this nature may result in damage to internal components, either directly or by allowing fluid to enter the device, however a definitive root cause of the damaged transistors cannot be established.Follow up with the user facility revealed that at the time of the incident, the ri-2 was plugged into a 20 amp ceiling pendant system along with the following devices: anaesthetic machine, cell saver, pc, and syringe pump.This 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." the use of the ceiling pendant system rather than a dedicated mains outlet can result in the circuit breaker tripping in theatres as reported, and is the reason for providing specific ac input voltage and ac receptacle requirements in the operator's manual.Belmont indicates that the system should be used on a dedicated line, as the system can draw a significant fraction of the circuit capabilities, and if the line is shared, the sum total of any two devices even when operating correctly, can cause the theatre breakers to trip.The conclusion reached is that this is an isolated incident which occurred due to a failure to follow the instructions provided in the operator's manual regarding ac input voltage and ac receptacle requirements for use of the ri-2 device.The manufacturing records for this serial number were reviewed and no anomalies were identified.The user facility indicated that another belmont rapid infuser was used to complete the case without further issue, there was no patient injury reported.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.

• 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: 11041383
• Report Number: 1219702-2020-00120
• Device Sequence Number: 1034070
• Product Code: LGZ
• UDI-Device Identifier: 00896128002817
• UDI-Public: (01)00896128002817
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 903-00039A-UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1