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

Model Number	3.0 LITER RESERVOIR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 3.0 liter reservoir involved in the incident was discarded at the hospital and was therefore not available for investigation.A video provided by the user facility confirms the reported leak from the bottom of the reservoir, however without the ability to investigate the device a root cause of the leak cannot be determined.A review of past complaints indicates that there have been no other complaints related to this lot number.No trend has been identified for this type of issue.It was reported that there was no injury to the patient.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's distributor received a report from the user facility about a 3.0 liter reservoir and reported the following: "blood leaked from the bottom port of the reservoir while using the large set.The exact part could not be confirmed.The kit was discarded on site.".

• 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: 11181547
• Report Number: 1219702-2021-00014
• Device Sequence Number: 2140748
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)230331(10)20200318
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

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 Expiration Date: 03/31/2023
• Device Model Number: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2020-03 18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1