XLUNG Kit 230
Received Jul 12, 2026 · Event occurred Jun 15, 2026
Report 3012172416-2026-00059 · MDR key 25790969
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXG2817
Product problems
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED A BLOOD LEAK FROM THE ARTERIAL SAMPLING PORT THAT OCCURRED ONE HOUR AND 40 MINUTES FOLLOWING THE INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE PATIENT HAD A BLOOD LOSS OF APPROXIMATELY 50 ML AS A RESULT OF THIS EVENT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE TO BE RETURNED FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.