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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump was returned to belmont for investigation; evaluation of the unit is in process.In the event of a "heater power i/o fault" alarm, as reported by the customer, the hyperthermia pump sounds an audible alarm and displays an alarm message with instructions for corrective measure.This particular alarm is a hardware alarm which occurs at power-up and therefore would not interrupt a procedure.The manufacturing records for this serial number were reviewed and nothing notable was observed; the unit has not been returned for service since it was shipped to the customer in 2016.There was no patient injury reported.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
The user facility reported that the hyperthermia pump was exhibiting "heater power i/o fault" alarms.
Additional Manufacturer Narrative
The hyperthermia pump involved in the incident was returned to belmont for investigation.It was determined that two transistors on one of the driver boards were damaged, which caused the unit to exhibit a "heater power i/o fault" alarm as reported.A root cause of the damaged transistors could not be established.When the hyperthermia pump recognizes a situtation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.In the event of a "heater power i/o fault" alarm, the hyperthermia pump displays the following alarm message: "power off and restart.Service machine if error persists." the manufacturing records for this serial number were reviewed and no anomalies were identified.The unit had not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2016.No patient injury was reported.Belmont will continue to monitor and trend 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
• MDR Report Key: 10497365
• Report Number: 1219702-2020-00068
• Device Sequence Number: 16878540
• 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 faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1