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 IN THE PUMP HEAD (FSXK2833¿035) COMING FROM X-LUNG 230 KIT F3200014 (BATCH UNKNOWN). VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT WAS STARTED FOR A PATIENT ON 6/JUN/2025. THE NOVALUNG KIT WAS PRIMED AND NO ISSUES WERE NOTED. AFTER CANNULATION, THE PRIMED NOVALUNG KIT WAS FOUND TO BE FULL OF AIR. THERE WERE NO OBVIOUS VISIBLE LEAKS. THE AIR WAS REMOVED AND AGAIN NO ABNORMALITIES WERE NOTED. THE SYSTEM WAS THEN CONNECTED TO THE PATIENT, AFTER WHICH LEAKAGE FROM THE PUMP HEAD WAS VISIBLE. THE KIT WAS EXCHANGED AS THE PATIENT REMAINED STABLE. THE PATIENT EXPERIENCED A BLOOD LOSS OF 200 ML AS A RESULT OF THIS EVENT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3, H6 PLANT INVESTIGATION: NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER, AND A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE WAS RECEIVED ON JUNE 17, 2025. BLOOD RESIDUES WERE VISIBLE ON THE EDGE BETWEEN THE INNER AND OUTER HOUSINGS OF THE PUMP HEAD. A SMALL LEAK WAS DETECTED BETWEEN THE INNER AND OUTER HOUSING. IT WAS FOUND THAT A SMALL PART OF THE PUMP HEAD HOUSING WAS NOT SUFFICIENTLY BONDED SO THAT LIQUID COULD LEAK BETWEEN THE HOUSING PARTS. THE ISSUE WAS FORWARDED TO THE PRODUCTION DEPARTMENT, AND MEASURES HAVE BEEN TAKEN TO AVOID THIS ERROR IN THE FUTURE.

Description of Event or Problem

A USER FACILITY REPORTED A LEAKAGE IN THE PUMP HEAD (FSXK2833¿035) COMING FROM X-LUNG 230 KIT F3200014 (BATCH UNKNOWN). VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT WAS STARTED FOR A PATIENT ON (B)(6) 2025. THE NOVALUNG KIT WAS PRIMED AND NO ISSUES WERE NOTED. AFTER CANNULATION, THE PRIMED NOVALUNG KIT WAS FOUND TO BE FULL OF AIR. THERE WERE NO OBVIOUS VISIBLE LEAKS. THE AIR WAS REMOVED AND AGAIN NO ABNORMALITIES WERE NOTED. THE SYSTEM WAS THEN CONNECTED TO THE PATIENT, AFTER WHICH LEAKAGE FROM THE PUMP HEAD WAS VISIBLE. THE KIT WAS EXCHANGED AS THE PATIENT REMAINED STABLE. THE PATIENT EXPERIENCED A BLOOD LOSS OF 200 ML AS A RESULT OF THIS EVENT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THE PUMP HEAD WAS EXCHANGED AS THE REST OF THE INITIAL XLUNG KIT 230 WAS KEPT IN PLACE. THE COMPLAINT SAMPLE WAS RETURNED TO XENIOS FOR PRODUCT EVALUATION.

Description of Event or Problem

A USER FACILITY REPORTED A LEAKAGE IN THE PUMP HEAD (FSXK2833¿035) COMING FROM X-LUNG 230 KIT F3200014 (BATCH UNKNOWN). VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT WAS STARTED FOR A PATIENT ON (B)(6) 2025. THE NOVALUNG KIT WAS PRIMED AND NO ISSUES WERE NOTED. AFTER CANNULATION, THE PRIMED NOVALUNG KIT WAS FOUND TO BE FULL OF AIR. THERE WERE NO OBVIOUS VISIBLE LEAKS. THE AIR WAS REMOVED AND AGAIN NO ABNORMALITIES WERE NOTED. THE SYSTEM WAS THEN CONNECTED TO THE PATIENT, AFTER WHICH LEAKAGE FROM THE PUMP HEAD WAS VISIBLE. THE KIT WAS EXCHANGED AS THE PATIENT REMAINED STABLE. THE PATIENT EXPERIENCED A BLOOD LOSS OF 200 ML AS A RESULT OF THIS EVENT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THE PUMP HEAD WAS EXCHANGED AS THE REST OF THE INITIAL XLUNG KIT 230 WAS KEPT IN PLACE. THE COMPLAINT SAMPLE WAS RETURNED TO XENIOS FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D3, D4, D9, G1. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.