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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump involved in the incident was returned to belmont for investigation and was tested according to our standard operating procedures.Upon receipt we found that the unit required a temperature calibration, which caused the unit to exhibit a "heating fault" alarm as reported.The system may exhibit a "heating fault" alarm when the temperature probes are out of calibration.In the event of a "heating fault" alarm, the rapid infuser displays the following alarm message: "check temperature probes for blockage.Clean windows.Press retry to continue.Service machine if error persists." the operator's manual provides the following recommended operator action: "check disposable set and flow path for occlusions.Make certain the windows on the disposable set and the ir probes are clean and dry.Clean surfaces with moistened soft cloth if necessary.Dry off surfaces before continuing.Press retry to continue.Power off and service machine if error persists." as dirty, wet, or blocked temperature probes can cause the rapid infuser to exhibit a "heating fault" alarm, the temperature probes should be cleaned before or after each use according to the service and preventive maintenance schedule provided in the operator's manual.The routine maintenance instructions in the operator's manual state: "keep the probe sensors clean and dry.If they become dirty or wet, clean with a moistened q-tip and dry.Use care not to damage the sensor surface." the manufacturing batch records for the disposable set were reviewed and no related anomalies were identified.It was reported that the case was completed and there was no injury to the patient.Should additional relevant information become available, a supplemental report will be provided.
Event or Problem Description
The user reported the following about a hyperthermia pump: "when running hyperthermia machine during a case, i received a heating fault alarm on the device when increasing the target temperature.I turned off the device and wiped down temp sensors, and rebooted machine, and received the same error message when device reached 40.5c.I then changed out the heat exchanger kit and then rebooted machine again and the issue was resolved for the rest of the case.".

• 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: 11704330
• Report Number: 1219702-2021-00055
• Device Sequence Number: 14317919
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: 04/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1