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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump involved in the incident was received by belmont for investigation on 2/25/2021; evaluation of the unit is in process.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 results of the investigation, it is difficult to determine what occurred in this case.A review of past complaints indicates that this was an isolated incident.No patient injury was reported.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
The user facility reported that the hyperthermia pump displayed incorrect temperature outputs at locations t1, t2, and t3.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11408165
• Report Number: 1219702-2021-00034
• Device Sequence Number: 11895277
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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 faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1