MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES HYPERTHERMIA PUMP-DISPOSABLE; WARMER, THERMAL, INFUSION FLUID

Catalog Number	902-00037
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The disposable set involved in this incident was discarded therefore could not be sent for review.It was reported that mitomycin-c was administered during the procedure which is a chemotherapeutic agent.The hyperthermia pump manual states that,"the hyperthermia pump¿ has not been evaluated for the delivery of chemotherapeutic agents".No patient impact was reported as a result of this incident.The cited disposable set was not available for investigation as it was contaminated.A thorough investigation could not be performed.A retain sample from the same lot was reviewed and no issues were identified.No device malfunction could be verified and the root cause could not be determined.The disposable set was not saved, therefore a thorough investigation of the disposable could not be performed.A sample from the same lot (#20231003) was inspected and no anomalies were identified.All disposable sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.Belmont will continue to monitor these issues moving forward.
Event or Problem Description
Belmont received medwatch #mw5154726 on may 30th, 2024 having below event description: during the hipec the heat exchanger disposable set began to leak shortly after the second dose of mitomycin-c was administered.Upon quickly noticing the leak, the hipec was paused and the disposable set that was leaking was exchanged with a new one.It appeared to be leaking from a connection that comes premade / glued from the manufacturer- the red piece of tubing that is connected to the top of the round metal heat exchanger itself.

• Brand Name: HYPERTHERMIA PUMP-DISPOSABLE
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 19637032
• Report Number: 1219702-2024-00030
• Device Sequence Number: 8673430
• Product Code: LGZ
• UDI-Device Identifier: 00896128002213
• UDI-Public: 00896128002213
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152208
• 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: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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 Catalogue Number: 902-00037
• Device Lot Number: 20231003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown