XLUNG KIT 230

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 REPORTED A LEAKAGE WHILE THE USER PERFORMED A LEAK TEST AND DETECTED FLUID LEAKAGE ON THE RECIRCULATION SIDE. THE FACILITY TESTED ALL THREE SETS STILL IN THE HOSPITAL. THE SETS WERE LISTED IN IN FSCA-2025-001--HILITE 7000 LT OXYGENATOR AS POTENTIALLY AFFECTED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. FOUR SIMILAR COMPLAINTS HAVE BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE PRODUCT WAS NOT RETURNED, AND A PHYSICAL INVESTIGATION COULD NOT BE CARRIED OUT. A POSSIBLE CAUSE OF THE LEAK IS A KNOWN DEFECT AT THE PORT. THE KNOWN CAUSE OF THE DEFECT IS A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT WHICH RESULTS IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. ALL OXYGENATORS ARE TESTED FOR LEAKAGES DURING PROCESS CONTROLS. IT IS ALSO POSSIBLE THAT FINE CRACKS MAY SUBSEQUENTLY OCCUR IN THE TEMPERATURE PORT DURING TRANSPORT OR HANDLING. RETENTION SAMPLE TESTING WAS NOT CARRIED OUT AS IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN A RETENTION SAMPLE.

Description of Event or Problem

A USER FACILITY REPORTED A LEAKAGE WHILE THE USER PERFORMED A LEAK TEST AND DETECTED FLUID LEAKAGE ON THE RECIRCULATION SIDE. THE FACILITY TESTED ALL THREE SETS STILL IN THE HOSPITAL. THE SETS WERE LISTED IN IN FSCA-2025-001--HILITE 7000 LT OXYGENATOR AS POTENTIALLY AFFECTED. UPON FOLLOW-UP, IT WAS REPORTED THAT BASED ON THE AVAILABLE INFORMATION AND BATCH REVIEW, A DIMENSIONAL DEVIATION IN THE RECIRCULATION PORT WAS DETERMINED TO BE THE CAUSE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.