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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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.We were unable to duplicate the report that the unit exhibited a "pump fault" alarm; the system performed according to our specifications upon receipt.When the hyperthermia pump recognizes a situation 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 "pump fault" alarm, the hyperthermia pump displays the following message: "check pump for blockage.Press retry to continue.Service machine if error persists." the operator's manual also provides possible conditions and recommended operator actions.Without the ability to confirm the complaint, it is difficult to establish a root cause of the reported "pump fault" alarm in this case.A review of past complaints indicates that this was an isolated incident.The manufacturing and service records for this serial number were reviewed and no related anomalies were identified.Another hyperthermia pump was used to proceed with the case; there was no injury to the patient.Belmont 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
During a hyperthermia case, the hyperthermia pump exhibited a "pump fault" alarm at start-up.

• 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: 11610401
• Report Number: 1219702-2021-00048
• Device Sequence Number: 14458560
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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: 03/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1