XLUNG KIT (USA)

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY DISCOVERED A CRACKED STOPCOCK ON PRE-MEMBRANE PIGTAIL OF THE XLUNG KIT (USA) DURING PRIMING OF THE STERILE CIRCUIT. THERE WAS A SIGNIFICANT LEAK AT THE POST-OXYGENATOR PIGTAIL THAT CAME FROM THE PROXIMAL LUER-LOCK OF THE THREE-WAY STOPCOCK. PICTURES WERE TAKEN AND THE CIRCUIT WAS SEQUESTERED FOR RETURN TO FRESENIUS. THE PICTURES WERE NOT PROVIDED AS IT WAS DETERMINED THEY DID NOT EFFECTIVELY SHOW THE BREAKAGE. A NEW KIT WAS THEN PRIMED WITHOUT INCIDENT. THERE WAS NO PATIENT INVOLVEMENT.