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

Model Number	PROCEDURE KIT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implicated disposable set has not been returned for investigation.Upon reviewing photos provided by the user facility, we were able to verify the reported leak; however, without inspecting the sample it is difficult to determine what occurred in this case.The library/retain sample for this lot number was inspected and no issues were observed.The manufacturing records for the associated lot were reviewed and there were no anomalies identified.A review of complaints for the past year indicated that there have been no other leaks reported involving this lot number.However, we will continue to monitor and trend similar reports of this nature.It was reported that there was no harm to the patient.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Our distributor received a complaint from the user facility and relayed the following report: "leakage of chemo-solution from the heat exchanger set was discovered during the hipec treatment cycle.We have replaced the whole consumable set continue the hipec treatment and the procedure was smooth after that.".

• 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: 9205493
• Report Number: 1219702-2019-00074
• Device Sequence Number: 16920880
• 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): 10/17/2019

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 Model Number: PROCEDURE KIT
• Device Catalogue Number: 902-00045
• Device Lot Number: 2019-02 11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1