XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4 PLANT INVESTIGATION: THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE AND/OR ON THE LABEL. NO QUALITY EVENTS REFER TO THE FAILURE PATTERN AT HAND. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. DUE TO 100% LEAK TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. THE CAUSE HAS BEEN IDENTIFIED DURING INVESTIGATION OF PREVIOUS COMPLAINTS AND A CAPA HAS BEEN IMPLEMENTED.

Description of Event or Problem

A USER FACILITY REPORTED A BLOOD LEAK OF APPROXIMATELY 50 ML THAT OCCURRED FOLLOWING ONE HOUR OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. PHOTOGRAPHIC EVIDENCE SHOWED A SMALL LEAK AT THE PRE-MEMBRANE SAMPLING PORT BEFORE THE THREE-WAY STOPCOCK. THE PATIENT CIRCUIT WAS NOT EXCHANGED AND THE PHYSICIAN USED STERILE GAUZE TO OCCLUDE THE LEAK. THERE WAS NO RESULTING PATIENT INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

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 BLOOD LEAK OF APPROXIMATELY 50 ML THAT OCCURRED FOLLOWING ONE HOUR OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. PHOTOGRAPHIC EVIDENCE SHOWED A SMALL LEAK AT THE PRE-MEMBRANE SAMPLING PORT BEFORE THE THREE-WAY STOPCOCK. THERE WAS NO SPECIFIED PATIENT INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.