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

Model Number	STRAIGHT INFLOW/BIFURCATED OUTFLOW PATIENT LINE
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implicated disposable set was returned for investigation and the reported leak at the heat exchanger was confirmed.The set was tested with water and a leak was identified in the joint between the heat exchanger and the nozzle.A visual examination of the material on either side of the joint showed evidence of stress.The retain sample for this lot number was also inspected and no problems were found.The manufacturing records for this lot number were reviewed and no anomalies were identified.When the hyperthermia pump recognizes a situation that may compromise safe and effective infusion, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.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 distributor received a complaint from the user facility and relayed the following report: "hyperthermia set was installed and the warming phase had begun.During the warming phase it was noticed fluid was leaking from the disposable.It was leaking from the heat exchanger.Forutnately the chemostatic solution had not been applied yet.The disposable was replaced and the case continued.".

• 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: 9742521
• Report Number: 1219702-2020-00020
• Device Sequence Number: 11391346
• Product Code: LGZ
• UDI-Device Identifier: 00896128002220
• UDI-Public: 00896128002220
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• 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 Expiration Date: 12/31/2021
• Device Model Number: STRAIGHT INFLOW/BIFURCATED OUTFLOW PATIENT LINE
• Device Catalogue Number: 902-00038
• Device Lot Number: 2018-12 09
• Was Device Available for Evaluation?: Yes
• 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