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

Model Number	3.0 LITER RESERVOIR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 3.0 liter reservoir involved in the incident was not available for investigation.A review of photographs provided by the user facility indicates evidence of potential residual adhesive in the tubing of the 3.0 liter reservoir, however the photographs are not detailed enough to determine the actual condition of the tubing.Without investigating the set, a root cause cannot be determined.The manufacturing batch records for this lot were reviewed and no related anomalies were identified.A review of past complaints indicates only one other report related to this lot number.All 3.0 liter reservoirs are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.It was reported that the reservoir was replaced; no patient injury was reported.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 that the spikes of a 3.0 liter reservoir came loose during a case.

• 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: 10826646
• Report Number: 1219702-2020-00099
• Device Sequence Number: 13934711
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)230531(10)20200504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/11/2020

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: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1