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

Model Number	RI-2
Medical Device Problem Codes	Output Problem (3005); No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser has not been returned to belmont for investigation.The manufacturing records for this serial number were reviewed and nothing notable was observed.This unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2016.Without additional information, it is difficult to determine what occurred in this case.A review of complaints for the past year indicate that this was an isolated incident; however, we will continue to monitor and trend similar reports of this nature.The user facility did not report any patient injury.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Belmont's distributer received a complaint from the user facility and relayed the following report."the touch screen intermittently stop function.A patient got transfused in various speed in a period of 90 minutes because of a bleeding aorta.But on the last phase of these 90 minutes they scaled it down to 50 ml/min, after this it came an error (101) that was possible to override, which they did and then it went up to 750 ml/min automatically and it wasn't possible to turn the speed down.It was constantly on 750 ml/min.When they tried to press "stop", the machine the stopped as long as they hold the button in, but it continued at 750 ml/min when they released the button.From there they didn't wasnt to risk the patient life and they had to get the other belmont they have at their hospital.".
Additional Manufacturer Narrative
The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation.The membrane switch was damaged, which prevented the touch screen from functioning properly as reported.Root cause of the damage was unknown.The manufacturing records for this serial number were reviewed and nothing notable was observed.This unit had not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2016.It was reported that another rapid infuser was used to proceed with the case.The user facility did not report any patient harm.Belmont will continue to monitor and trend similar reports of this nature.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERNAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd; billerica, ma
• Manufacturer Contact: joelle haun ; 780 boston rd; billerica, ma
• MDR Report Key: 9703206
• Report Number: 1219702-2020-00013
• Device Sequence Number: 16571272
• Product Code: LGZ
• UDI-Device Identifier: 10896128002777
• UDI-Public: (01)10896128002777
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K141564
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2016
• 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