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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was returned for investigation and was tested using our standard operating procedures.We were unable to confirm the customer complaint that the device was sounding an audible alarm without providing an error message on the screen.However, upon receipt, it was noted that a wire on one of the external temperature probe cables was broken, which prevented the unit from reading the external temperature from the probe.The disposable set was not returned for investigation, however, the retain sample of the lot number provided was reviewed and nothing notable was observed.We will continue to contact the user facility for further details about the incident.Without additional information, it is difficult to determine what occurred in this case.There was no patient injury reported.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Belmont's sales representative received a complaint from the user facility and relayed the following report: "during case an audible alarm continuously sounded without providing error message on screen.Temperatures, pressure and flow rate all remained stable while alarming.This occurred routinely during machine periodic re-prime and randomly throughout procedure.".

• 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: 8642897
• Report Number: 1219702-2019-00033
• Device Sequence Number: 16598239
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 05/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1