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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump has not been returned to belmont for investigation.Upon receiving the complaint, belmont's clinical specialist recommended that the user facility attach the anesthesia department's temperature cable to the probes in order to determine whether the issue was with the probes, the cables, or the device.We have contacted the distributor, but have not yet received any follow-up information.Without additional information, it is difficult to determine what occurred in this case.When the hyperthermia pump recognizes a situation that is compromising effective infusing, it stops pumping and heating, closes off the line to the patient, displays an alarm message with instructions for corrective measure, and sounds an audible alarm.It was reported that there was no injury to the patient.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Belmont's clinical specialist received a complaint from the user facility and relayed the following report: "i received an after hours call concerning an issue with a hyperthermia pump and not having any temperature readings.Upon calling them back i spoke with (b)(6) and she told me that none of the four temperature readings were showing on the hyperthermia machine she was using.I asked for her to attach anesthesia's temperature cable to the probes in order to determine if the issue was with the probes, cables or machine.She said she would do that and follow up with repair of the machine if it was determined that it was necessary.".

• 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: 9741132
• Report Number: 1219702-2020-00019
• Device Sequence Number: 16772620
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: 10896128002456
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1