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

Model Number	INFLOW/OUTFLOW PATIENT LINE KIT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable set involved in the incident is not available for investigation, therefore a root cause of the reported leak cannot be established.The manufacturing batch records for this lot were reviewed and no related anomalies were identified.All disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates that there have been no other complaints related to this lot number.No patient injury was reported.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported that the hyperthermia pump disposable set leaked at the heat exchanger during use.

• 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: 12530889
• Report Number: 1219702-2021-00124
• Device Sequence Number: 4031743
• Product Code: LGZ
• UDI-Device Identifier: 00896128002213
• UDI-Public: (01)00896128002213(17)240131(10)20210103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/25/2021

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: 01/31/2024
• Device Model Number: INFLOW/OUTFLOW PATIENT LINE KIT
• Device Catalogue Number: 902-00037
• Device Lot Number: 2021-01 03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1