MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION HYPERTHERMIA PUMP ST IN/OUT PT LINE; WARMER, THERMAL, INFUSION FLUID

Model Number	902-00039P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Shortly after beginning circulation of chemotherapy solution via belmont hyperthermia pump, i noticed a leak coming from the bottom of the floor of the device.I promptly notified the surgeon and stopped the infusion.Upon opening the pump door which houses the disposable heat exchanger, i observed a leak at the connector portion about the heat exchanger ring.Realizing there was no way to fix the disposable, i alerted the surgeon that the heat exchanger portion would need to be replaced, to which she agreed.I cleaned the leak-contaminated areas per the protocol and replaced the damaged heat exchanger with a new one of a new lot number in a sterile fashion.We then restarted reinfusion and experienced no further issues.

• Brand Name: HYPERTHERMIA PUMP ST IN/OUT PT LINE
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston road; billerica MA 01821
• MDR Report Key: 15461858
• Report Number: 15461858
• Device Sequence Number: 4322773
• Product Code: LGZ
• UDI-Device Identifier: 00896128002169
• UDI-Public: 00896128002169
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2022
• Report Date (Section F): 09/09/2022

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
• Device Model Number: 902-00039P
• Device Lot Number: 2022-05 09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White
• Date Report Sent to FDA: 09/09/2022