MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER, RI-2; PUMP, INFUSION

Model Number	902-00039P
Medical Device Problem Code	Fluid/Blood Leak (1250)
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
In the procedure for recurrent peritoneal malignant mesothelioma; ventral hernia, shortly after beginning circulation of chemotherapy solution via belmont hyperthermia pump, nurse noticed a leak coming from the bottom of the floor of the device.The nurse promptly notified the surgeon and stopped the infusion.Upon opening the pump door which houses the disposable heat exchanger, a leak was observed at the connector portion of the heat exchanger ring.Realizing there was no way to fix the disposable, after which the leak-contaminated areas were cleaned per the protocol and replaced the damaged heat exchanger with a new one of a new lot number in a sterile fashion.Re infusion was restarted and there were no further issues.
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The device involved in the incident was not returned to belmont medical technologies for evaluation.The patient involved in this event was not harmed.Medwatch# (b)(4) was received in relation to this alleged incident on (b)(6) 2022.In the procedure for recurrent peritoneal malignant mesothelioma; ventral hernia, shortly after beginning circulation of chemotherapy solution via belmont hyperthermia pump, nurse noticed a leak coming from the bottom of the floor of the device.The nurse promptly notified the surgeon and stopped the infusion.Upon opening the pump door which houses the disposable heat exchanger, a leak was observed at the connector portion of the heat exchanger ring.Realizing there was no way to fix the disposable, after which the leak-contaminated areas were cleaned per the protocol and replaced the damaged heat exchanger with a new one of a new lot number in a sterile fashion.Re infusion was restarted and there were no further issues.The belmont hyperthermia pump is not indicated for use with chemotherapeutic agents.The opertaor' maual also has a caution,"the hyperthermia pump¿ has not been evaluated for the delivery of chemotherapeutic agents".Despite this the user confirmed that chemotherapy solution was used in this case.The operator's manual also provides instructions on installing the disposable set and additional recommended operator actions.The step-by-step procedures in manual has warning on installing the disposable, "do not kink or twist the tubing" and "do not apply excessive pressure to the pressure transducer.The pressure transducer can be damaged with excessive force.Do not use the system if the pressure transducer is damaged" we followed-up with the nurse at the user facility, she confirmed that the disposable was discarded and is therefore not available for evaluation.It was also confirmed that there are no additional details available for the incident.Manufacturing batch records for the lot were reviewed and no issues were found.It was determined that there are no other complaints associated with devices from the same lot as the alleged device.The issue could not be verified and a root cause of the reported leak could not be identified.All belmont® 3 spike disposable sets are 100% leak tested and 100% visually inspected prior to final packaging and release for shipment from belmont medical technologies.No device malfunction could be verified and the root cause could not be determined.We did confirm that chemotherapy solution was used, contrary to operator manual instructions but cannot confirm that use of an unknown chemotherapy solution caused the reported leak.We will continue to monitor and trend similar reports closely and take further corrective and preventive actions if required.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Common Device Name: PUMP, INFUSION
• 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: 15655057
• Report Number: 1219702-2022-00035
• Device Sequence Number: 12253708
• Product Code: LGZ
• UDI-Device Identifier: 00896128002169
• UDI-Public: 00896128002169
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K141654
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: 902-00039P
• Device Catalogue Number: 902-00039
• Device Lot Number: 2022-05 09
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown