CADD CASSETTE RESERVOIRS - FLOW STOP

Description of Event or Problem

IT WAS REPORTED THAT WHILE PREPARING TO FILL THE CHEMICAL SOLUTION, LIQUID LEAKAGE WAS OBSERVED FROM THE CASSETTE AND TUBE CONNECTION. THE EVENT OCCURRED IN (B)(6) 2024. THE SAMPLE WAS AVAILABLE FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

B3: DAY OF EVENT IS UNKNOWN. DEVICE EVALUATION: THREE PICTURES WERE ATTACHED TO THE COMPLAINT. IN ONE OF THESE PICTURES, THERE IS A LEAK IN THE TUBE AND LUER CONNECTION. ONE SAMPLE WAS RETURNED IN USED CONDITION IN A PLASTIC BAG. DURING THE VISUAL INSPECTION OF THE DEVICE, NO DISCREPANCIES WERE FOUND IN THE DEVICE. DURING THE FUNCTIONAL TESTING, A LEAK WAS DETECTED BETWEEN THE LUER AND THE TUBE. THE FAILURE MODE OF ¿LEAKING¿ WAS CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.