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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump was received for evaluation on (b)(6) 2020.The investigation is not yet complete.When the hyperthermia pump recognizes a situation that is compromising effective infusing, it stops pumping, heating, moves the valve wand into recirculate position, displays alarm message, instructions for corrective measure, and sounds an audible alarm.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
Belmont's clinical specialist received a complaint from the user facility and relayed the following report: "the doctor was experiencing an error 204, heater power i/o fault during the hipec case.At the time he was changing the target temp from 45 c to 48 c at max flow rate of 1000 ml/min.The unit was recently sent back in october 2019 with output temp being dropped but belmont repair tech was unable to duplicate or confirm the issue.".
Additional Manufacturer Narrative
The hyperthermia pump involved in the incident was returned to belmont for investigation.We were unable to confirm the complaint that the unit exhibited a "heater power i/o fault" alarm.Upon receipt it was noted that the output temperature probe sensor was dirty, otherwise the unit performed according to specification.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 provided in the operator's manual instructs the user: "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." when the hyperthermia pump recognizes a situation that may compromise 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 (system error #204) the hyperthermia pump sounds an audible alarm and displays an alarm message with instructions for corrective measure.The operator's manual also provides possible conditions and additional recommended operator actions.There was no patient injury 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: 9729804
• Report Number: 1219702-2020-00018
• Device Sequence Number: 19343099
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 02/04/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/19/2020
• 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