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 THAT AN XLUNG KIT 230 WAS PRIMED FOR BACKUP TO AN ACTIVELY SUPPORTED EXTRACORPOREAL MEMBRANE OXYGENATION PATIENT. IT CIRCULATED SINCE (B)(6) 2026, WITH A CLOSED CIRCUIT WITHOUT THE FILLING LINE. ON (B)(6) 2026, AIR WAS DETECTED IN THE OXYGENATOR, PUMP HEAD AND IN PARTS OF THE PATIENT CIRCUIT. DURING VISUAL INSPECTION ON SITE, NO DAMAGE TO THE KIT WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. USERS ARE INSTRUCTED TO UTILIZE DE-AIRING TECHNIQUES DURING PRIMING AND PRIOR TO PATIENT APPLICATION TO ENSURE PATIENT SAFETY. AS AIR CAN ONLY BE ENTRAINED WHILE THE CIRCUIT IS OPEN TO ATMOSPHERE DURING PRIMING AND SHOULD BE CLOSED UNTIL PATIENT APPLICATION, IT WAS DETERMINED THAT THE EVENT WAS AN UNINTENDED USER ERROR.

Description of Event or Problem

A USER FACILITY REPORTED THAT AN XLUNG KIT 230 WAS PRIMED FOR BACKUP TO AN ACTIVELY SUPPORTED EXTRACORPOREAL MEMBRANE OXYGENATION PATIENT. IT CIRCULATED SINCE JANUARY 12, 2026, WITH A CLOSED CIRCUIT WITHOUT THE FILLING LINE. ON JANUARY 21, 2026, AIR WAS DETECTED IN THE OXYGENATOR, PUMP HEAD AND IN PARTS OF THE PATIENT CIRCUIT. DURING VISUAL INSPECTION ONSITE, NO DAMAGE TO THE KIT WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION; HOWEVER, THE DEVICE WAS NOT RETURNED BY THE USER FACILITY.