XLUNG KIT 230
Received Aug 12, 2025 · Event occurred Jun 5, 2025
Report 3012172416-2025-00076 · MDR key 22781734
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXB1901
Product problems
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
Patient
NA · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9. H3, H4 PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS AND NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE PRODUCT COULD NOT BE RETURNED FOR EVALUATION AND A DEFINITIVE CAUSE FOR THE LEAK OR THE CRACK COULD NOT BE CONFIRMED. A PHOTO HAS BEEN PROVIDED SHOWING A BLOOD LEAK THAT CAME FROM THE RECIRCULATION PORT, AND THERE WAS A CRACK NEAR THE POST MEMBRANE PORT. STRESSES MAY HAVE OCCURRED IN THE MATERIAL DURING THE INJECTION MOLDING PROCESS OR DURING DEMOLDING OF THE INJECTION-MOLDED PART. THE CRACK MAY HAVE SUBSEQUENTLY BEEN CAUSED BY THE RELEASE OF MATERIAL STRESS; FOR EXAMPLE, DURING HANDLING, E.G. TIGHTENING OF THE CONNECTION OR TRANSPORT. THE OXYGENATOR COMPONENT WAS PRODUCED ON NOVEMBER 23, 2023. THE INJECTION MOLDING TOOL HAS BEEN REPLACED SINCE THEN.
Description of Event or Problem
A USER FACILITY REPORTED THAT FOLLOWING INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, BLOOD WAS FOUND DRIPPING FROM THE POST-MEMBRANE PORT OF THE OXYGENATOR. UPON INSPECTION, BLOOD WAS LEAKING FROM A CRACK NEAR THE POST-MEMBRANE PORT. THE PATIENT HAD A REPORTED TOTAL BLOOD LOSS OF 50 ML. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. UPON FOLLOW-UP WITH THE FACILITY, IT WAS REPORTED THE PATIENT CONTINUED SUPPORT WITH A DIFFERENT DEVICE AND XLUNG KIT 230. THE PATIENT REQUIRED VOLUME SUBSTITUTION DUE TO BLOOD LOSS. THE COMPLAINT SAMPLE WAS INITIALLY AVAILABLE BUT NOT RETURNED FOR PRODUCT EVALUATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT FOLLOWING INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, BLOOD WAS FOUND DRIPPING FROM THE POST-MEMBRANE PORT OF THE OXYGENATOR. UPON INSPECTION, BLOOD WAS LEAKING FROM A CRACK NEAR THE POST-MEMBRANE PORT. THE PATIENT HAD A REPORTED TOTAL BLOOD LOSS OF 50 ML. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. UPON FOLLOW-UP WITH THE FACILITY, IT WAS REPORTED THE PATIENT CONTINUED SUPPORT WITH A DIFFERENT DEVICE AND XLUNG KIT 230. THE PATIENT REQUIRED VOLUME SUBSTITUTION DUE TO BLOOD LOSS. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.