MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES HEAT EXCHANGER SET (1 PIECE); WARMER, THERMAL, INFUSION FLUID

Model Number	902-00006P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported a leak in the hyperthermia pump disposable.The heat exchanger component developed a leak after the first chemo drug was added.It was changed with the same lot number and case continued uneventfully.However, the disposable event in this incident was discarded due to contamination.
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 not returned to belmont for evaluation since it was discarded due to contamination.The medwatch has date of event as aug 7th whereas, we were informed that the date of the event was 6th aug by the user.Incident was initially reported to belmont by the user on aug 6th, 2024 that there was a leak in the hyperthermia pump disposable.The heat exchanger component developed a leak after the first chemo drug was added.It was changed with the same lot number and case continued uneventfully.However, the disposable event in this incident was discarded due to contamination.There is no patient harm associated with this incident.Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, we received medwatch report #mw5158386 on sept 5th, 2024, which per our procedure requires us to submit a report.It was reported that chemo drugs were added to the device.The hyperthermia pump manual states that, "the hyperthermia pump¿ has not been evaluated for the delivery of chemotherapeutic agents".It could not be determined if the addition of the chemo drugs contributed to the reported leak.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 not available therefore could not be reviewed.No device malfunction could be verified and the root cause could not be determined.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.

• Brand Name: HEAT EXCHANGER SET (1 PIECE)
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica
• 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: 20363173
• Report Number: 1219702-2024-00043
• Device Sequence Number: 7979460
• Product Code: LGZ
• UDI-Device Identifier: 00896128002145
• UDI-Public: 00896128002145
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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 Model Number: 902-00006P
• Device Lot Number: 2022-05-05
• 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: 08/07/2024
• Initial Report FDA Received Date: 10/03/2024
• 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