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

Model Number	THE BELMONT HYPERTHERMIA PUMP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable set involved in this case was not returned for investigation.An inspection of the retention sample from the associated lot revealed no anomalies or defects.The manufacturing records of the associated lot were also reviewed and nothing notable was observed.It is unusual for the disposable set to start leaking after it has been in use for over an hour and infusing at a high rate of 1000ml/min, as reported by the user facility.We will follow up with the user facility to try to obtain any additional information.It was reported that there was no harm to the patient.Should any additional information become available, a supplemental report will be submitted accordingly.We will continue to monitor and trend reports of this nature.
Event or Problem Description
The user facility reported the following: "during hp case, tubing leaked at the plastic to plastic connection below the lura-lock connection below the machine.The leak was stopped using skin glue and a tageaderm.".

• 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: 8467083
• Report Number: 1219702-2019-00017
• Device Sequence Number: 10811252
• Product Code: LGZ
• UDI-Device Identifier: 00896128002206
• UDI-Public: (01)00896128002206
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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 Expiration Date: 07/31/2021
• Device Model Number: THE BELMONT HYPERTHERMIA PUMP
• Device Catalogue Number: 902-00034P
• Device Lot Number: 2018-07 06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1