MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION THE BELMONT HYPERTHERMIA PUMP; THERMAL INFUSION FLUID WARMER

Catalog Number	902-00001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation on april 4, 2018.Upon testing the unit using our standard operating procedures, the customer complaint was confirmed.The unit exhibited a heating fault alarm due to a dirty output temperature probe window.In the event of a heating fault alarm, the hyperthermia pump displays the following alarm message: "check temperature probes for blockage.Clean windows.Press retry to continue.Service machine if error persists." rebooting the machine without cleaning the temperature probe windows will not resolve the problem.There was no harm to the patient.
Event or Problem Description
The user facility reported that the hyperthermia pump exhibited a heating fault alarm with the following alarm message: "check temperature probe windows for blockage." the machine was rebooted and the procedure proceeded as planned.Near the end of the case, the unit exhibited another heating fault alarm.There was no adverse impact to the patient.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston road; billerica MA 01821
• MDR Report Key: 7449143
• Report Number: 1219702-2018-00003
• Device Sequence Number: 18868103
• 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: K090089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: No Information
• Device Catalogue Number: 902-00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1