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	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implicated disposable set was returned for investigation; we were unable to verify the reported leak.The returned set was tested with water under very little pressure which did not reveal any leaking.The set was then placed into a shallow layer of water and low pressure air was applied.This again confirmed no leaking.The retain sample for this lot number was inspected and it did not display this defect.The manufacturing records for this lot number were also reviewed and no anomalies were identified.Review of complaints for the past year indicate one report of this failure mode.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.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Belmont's distributor in the (b)(4) received a complaint from the user facility and relayed the following report: "leakage incident, hipec case on (b)(6) 2020.Hyperthermia set was installed.After the warming phase was run through the chemostatic agent was added to the fluid.During the chemoperfusion a leak was noticed.The leak was small and it was decided to continue the procedure since it would be more dangerous to exchange the set with regards to exposure of personnel to chemo.The chemo contaminated disposable was preserved in double packaging for belmont.".

• 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: 9772079
• Report Number: 1219702-2020-00023
• Device Sequence Number: 14086691
• 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): 02/07/2020

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: 02/07/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1