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.
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