XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. DUE TO 100% TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. FURTHERMORE, NO OTHER COMPLAINTS REGARDING THIS ISSUE WERE REPORTED REGARDING THIS BATCH NUMBER. AS THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A DEFINITIVE CAUSE OF THE DESCRIBED LEAK COULD NOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION, A CRACK IN THE BLOOD SAMPLE PORT COULD HAVE CAUSED THE LEAK. MATERIAL STRESS MAY OCCUR DURING THE INJECTION MOLDING PROCESS AND SMALL CRACKS CAN BE SUBSEQUENTLY CAUSED BY THE RELEASE OF MATERIAL STRESS, FOR EXAMPLE DURING HANDLING, E.G. TIGHTENING OF THE CONNECTION OR TRANSPORT. THE OXYGENATORS FOR THIS XLUNG KIT 230 CN WERE PRODUCED IN SEPTEMBER 2022. THE INJECTION MOLDING TOOL FOR THE OXYGENATOR HOUSING HAS BEEN REPLACED SINCE THEN.

Description of Event or Problem

A USER FACILITY REPORTED THAT A BLOOD SAMPLE PORT HAD BLOOD LEAKAGE FOLLOWING 60 MINUTES OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION. THE PATIENT LOST APPROXIMATELY 20 ML OF BLOOD. UPON FOLLOW-UP, IT WAS REPORTED THE PATIENT CIRCUIT WAS NOT EXCHANGED AND THE LEAK WAS OCCLUDED WITH GAUZE. THERE WAS NO RESULTING PATIENT SERIOUS INJURY AS A RESULT OF THIS EVENT.

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 THAT A BLOOD SAMPLE PORT HAD BLOOD LEAKAGE FOLLOWING 60 MINUTES OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION. THE PATIENT LOST APPROXIMATELY 20 ML OF BLOOD. UPON FOLLOW-UP, IT WAS REPORTED THE PATIENT CIRCUIT WAS NOT EXCHANGED AND THE LEAK WAS OCCLUDED WITH GAUZE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.