QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 W

Additional Manufacturer Narrative

THE DEVICE WAS DISCARDED BY THE CUSTOMER AFTER USE; THEREFORE, IT WAS NOT POSSIBLE TO PERFORM AN INVESTIGATION ON THE RETURNED UNIT. NO PATIENT HARM OR ADVERSE EFFECTS WERE REPORTED, AND THE LEAKAGE WAS CONTAINED WITHOUT FURTHER CONSEQUENCES. SIMILAR EVENTS WILL CONTINUE TO BE MONITORED THROUGH THE POST-MARKET SURVEILLANCE PROCESS.

Description of Event or Problem

BLOOD NOTED IN GLYCOL COMPARTMENT OF HEX - APPEARED TO BE A FAULT IN THE SEAM LINE BETWEEN THE GLYCOL COMPARTMENT AND THE BLOOD CHANNEL. DID NOT APPEAR TO RUPTURE, BLOOD APPEARED TO BE CONTAINED. CLINICIAN DISCARDED THE HEX FOLLOWING THE PROCEDURE.