MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT HYPERTHERMIA PUMP; THERMAL INFUSION FLUID WARMER

Catalog Number	902-00006P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implicated disposable set was discarded by the user facility and was therefore not returned to belmont for investigation, nor were any photos provided for review.The library/retain sample for the associated lot was inspected and no defects were observed.The manufacturing records for this lot number were reviewed and there were no anomalies identified.It was reported that the disposable set was replaced and the procedure continued.No patient harm was reported.We will continue to monitor and trend similar reports of this nature.
Event or Problem Description
Belmont's distributor received a complaint from the user facility and relayed the following report: "a leak in the heat exchanger in the distal end few minutes after the beginning of the chemotherapy.They changed the kit and continued with procedure.The set was discarded of.".

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 9413100
• Report Number: 1219702-2019-00093
• Device Sequence Number: 2933862
• Product Code: LGZ
• UDI-Device Identifier: 00896128002145
• UDI-Public: 00896128002145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152208
• 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): 12/04/2019

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: 02/28/2022
• Device Catalogue Number: 902-00006P
• Device Lot Number: 2019-02 01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1