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

Model Number	HYPERTHERMIA PUMP
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	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was returned for investigation and was tested using our standard operating procedures.The complaint of a burning smell was not confirmed, however, upon receipt it was confirmed that the unit exhibited a "pump fault" alarm due to a loose set screw and pins on the roller pump.As a result of the loose set screw and pins, the roller pump was hitting the chassy, which shorted two transistors and an integrated circuit on the daughter board.The operator's manual states that the device should be serviced periodically and includes a service and preventive maintenance schedule, which states that the pump head should be cleaned annually.The manual provides instructions for cleaning the pump head and instructs the user to "make certain the pump head is securely fastened with the retaining screw." the unit had not been returned to (b)(4) since it was shipped to the customer in 2013.It was reported that there was no injury to the patient nor a delay in therapy.
Event or Problem Description
The user facility reported that a "burnt smell" was noted right after the start of a procedure.About 3 to 5 minutes later, the unit displayed a "pump fault" alarm message and "the unit immediately stopped." when the unit was returned to the distributor, it was noted that there were scratches on the unit and misplaced pins on the roller pump assembly.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT INSTRUMENT LLC; 780 boston road; billerica MA 01821
• MDR Report Key: 7839669
• Report Number: 1219702-2018-00027
• Device Sequence Number: 16523284
• Product Code: LGZ
• UDI-Device Identifier: 10896128002135
• UDI-Public: (01)10896128002135
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HYPERTHERMIA PUMP
• Device Catalogue Number: 902-00001A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1