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	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 3.0 liter reservoir involved in the incident was not available for investigation, nor was a lot number provided.Without the ability to investigate the set, a root cause of the loose spikes and subsequent fluid leak cannot be established.All 3.0 liter reservoirs are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates that no trend has been identified for this type of issue with the 3.0 liter reservoir.No patient injury was reported.Belmont's sales representative has contacted the user facility to try to obtain the lot number of the 3.0 liter reservoir involved.Should a lot number become available, further investigation will be conducted on the associated retain sample.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's sales representative received a report from the user facility that a 3.0 liter reservoir was leaking during a case.The user reported that two of the five spikes were loose; the blood product was switched to the spikes that were not loose.The user also reported that a similar incident recently occurred during a trauma case, however no additional details were 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: 11179921
• Report Number: 1219702-2021-00010
• Device Sequence Number: 2947247
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: 00896128002008
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: 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: 12/15/2020
• 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