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

Model Number	3.0 LITER DISPOSABLE SET
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implicated disposable set has not been returned for investigation.The manufacturing records for this lot were reviewed and no anomalies were identified.No patient injury was reported.The investigation is not yet complete.A follow-up report will be submitted.
Event or Problem Description
Belmont's distributor received a complaint from the user facility and relayed the following report: "leakage, lower part of the reservoir.".

• 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: 9433481
• Report Number: 1219702-2019-00094
• Device Sequence Number: 2669831
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: 00896128002008
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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: 06/30/2022
• Device Model Number: 3.0 LITER DISPOSABLE SET
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2019-06 08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1