XLUNG KIT 230
Received May 28, 2026 · Event occurred May 12, 2026
Report 3012172416-2026-00041 · MDR key 25314756
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXH2504
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
Male
- No Clinical Signs, Symptoms or Conditions
Narrative
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 PATIENT WAS RESUSCITATED DURING PERCUTANEOUS CORONARY INTERVENTION. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT WAS STARTED ON (B)(6) 2026 AT 13:00 (LOCAL). ON (B)(6) 2026 AROUND NOON, THE PERFORMANCE OF THE OXYGENATOR WAS DEEMED LOW. AT 4.0 L OXYGEN GAS FLOW, 4.5 L OF BLOOD FLOW AND A FRACTION OF INSPIRED OXYGEN OF 100%, THE ARTERIAL OXYGEN WAS AT 14 KPA (PER LOCAL (B)(6) HOSPITAL THAT UTILIZES KPA, EQUIVALENT IS 105 MMHG). ON (B)(6) 2026, THE KIT WAS EXCHANGED. THE BATCH NUMBER OF THE KIT IS UNKNOWN, AS THE PACKAGING HAS BEEN DISCARDED. THE BATCH NUMBER OF THE OXY IS 32190008. THE LOCAL TECHNICAL TEAM HAS NOT DOWNLOADED THE LOGFILE YET BECAUSE THE PATIENT IS CRITICALLY ILL AND BEING CONNECTED TO VENOARTERIAL-VENOUS ECMO SUPPORT AS WELL AS AN IMPELLA. THE MACHINE LOGFILE WILL BE RETRIEVED ONCE THE CONSOLE IS AVAILABLE. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.