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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump has not been returned to belmont for investigation.To ensure safe operation, the system monitors sterile solution temperature, line pressure, and air in the fluid path, and alarms at all unsafe conditions.The hyperthermia pump system monitors patient temperature in four locations; the operator's manual instructs the user: "plug the external temperature interface cables to the hyperthermia pump, labeled t1, t2, t3 and t4, as needed." without evaluating the hyperthermia pump, it is difficult to determine what occurred in this case.The manufacturing records for this serial number were reviewed and nothing notable was observed.A review of complaints for the past three years indicates that this was an isolated incident.It was reported that there was no harm to the patient, nor a delay in treatment.We will continue to monitor and trend similar reports of this nature.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's sales representative received a complaint from the user facility and relayed the following report: "during procedure, t2 did not display temperature on screen.Patient unharmed and did not delay patient care.".
Additional Manufacturer Narrative
The hyperthermia pump involved in the incident was returned to belmont for investigation.Belmont was unable to confirm the report that the external temperature at location t2 did not display the temperature.External temperatures t1 to t4 were all verified, as well as all pc boards and cables in the system.All were properly connected and functioning properly; the unit performed according to specifications upon receipt.To ensure safe operation, the system monitors sterile solution temperature, line pressure, and air in the fluid path, and alarms at all unsafe conditions.The hyperthermia pump system monitors patient temperature in four locations; the operator's manual instructs the user: "plug the external temperature interface cables to the hyperthermia pump, labeled t1, t2, t3 and t4, as needed." the manufacturing records for this serial number were reviewed and nothing notable was observed.A review of complaints for the past three years indicates that this was an isolated incident.It was reported that there was no harm to the patient, nor a delay in treatment.We will continue to monitor for similar reports of this nature.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, ma ; 3307637
• MDR Report Key: 10411179
• Report Number: 1219702-2020-00058
• Device Sequence Number: 2642876
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• Combination Product (Y/N): N
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: HYPERTHERMIA PUMP
• Device Catalogue Number: 902-00001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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