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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Codes	Restricted Flow rate (1248); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump involved in the incident has not been returned to belmont for investigation and the users were unable to provide the lot number of the disposable set involved, therefore we are unable to confirm the reported "high temperature" alarm or limited return flow within the tubing.Follow up with the user facility revealed that the problem was resolved and no issues occurred as a result of the incident.The physician believes the "high temperature" alarm may have been the result of the cannula being stuck or a piece of tissue caught in the tubing.In the event of an "over temperature" alarm, the hyperthermia pump displays the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions, which includes checking for restricted flow or a clogged filter.The manual also provides possible conditions and recommended operator actions in the event that the flow rate is slowing down or will not go at the set rate.The manufacturing records for the hyperthermia pump were reviewed and no anomalies were identified.It was reported that there was no injury to the patient.The case is considered closed at this time.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's sales representative received a report from the user facility involving a hyperthermia pump and reported the following: "during case they received limited return flow and were unable to maintain a high rate of perfusion.At the end of the case they flushed the patient with 6 l of sterile water and received a high temperature alarm.Flow was paused to let machine cool before continuing without issue.Doctor suggested it could have been a one off situation but i've asked perfusion for the disposable lot number and will update with additional information.".

• 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: 11381830
• Report Number: 1219702-2021-00031
• Device Sequence Number: 14462469
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1