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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility was unable to return the implicated set for investigation.The retention sample from the reported lot was inspected and there were no anomalies or defects found.The manufacturing records of the associated lot were also reviewed and nothing notable was observed.The users were able to successfully complete the procedure after replacing the set.It was reported that the patient was not injured.Should additional information become available, a supplemental report will be submitted accordingly.We will continue to monitor and trend similar reports of this nature.
Event or Problem Description
Our distributor received a complaint from the user facility and relayed the following report: "during a case the solution keeps leaking out near the heater exchange.They have cleaned it once and resumed the procedure but the problem persists.Finally, it was solved eventually by replacing the set with their backup set.Hence, they would like to ask to have a replacement of the kit.They are not able to return the defected set since it is already contaminated by chemo solution.".

• 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: 8559627
• Report Number: 1219702-2019-00025
• Device Sequence Number: 2339518
• Product Code: LGZ
• UDI-Device Identifier: 00896128002589
• UDI-Public: 00896128002589
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2019

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 Model Number: HYPERTHERMIA PUMP
• Device Catalogue Number: 902-00045
• Device Lot Number: 2019-02 10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1