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	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2021
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.Review of the photograph and video provided indicates partial clotting within the reservoir as reported.The user facility was unable to provide the lot number of the disposable set, however through a review of the hospital's order history we were able to determine two lot numbers recently shipped and therefore potentially involved.The manufacturing batch records for these lots 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 this was an isolated incident.There have been no other complaints related to the potential lot numbers involved in the incident.The hospital is unwilling to release details about the patient.It was reported that the fluids added to the reservoir included saline, red blood cells, and fresh frozen plasma.The operator's manual cautions the user to replace the reservoir chamber or disposable set when the filter becomes clogged.Without the ability to investigate the reservoir, the root cause of the reported clotting cannot be established.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported the following: "they were running the belmont with their standard setup (3.0 l reservoir) during a trauma case.The patient arrested and they needed to do cpr.During cpr it was recognized that the blood in the reservoir had partially been clotted.".

• 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: 11830099
• Report Number: 1219702-2021-00069
• Device Sequence Number: 14336415
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: 00896128002008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2021

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 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: 04/15/2021
• Initial Report FDA Received Date: 05/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1