XLUNG KIT 230
Received May 13, 2026 · Event occurred Apr 12, 2026
Report 3012172416-2026-00038 · MDR key 25158656
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXH0418
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Cardiac Arrest
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
THE PLANT INVESTIGATION AND CLINICAL INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THESE ACTIVITIES.
Description of Event or Problem
A USER FACILITY REPORTED A PATIENT WHO PRESENTED WITH SEVERE PNEUMONIA, SEPTIC SHOCK AND CARDIAC ARREST WAS PLACED ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. AN ABNORMAL NOISE OCCURRED IN THE PUMP HEAD AFTER A HALF HOUR OF SUPPORT, AND THE BLOOD FLOW RATE COULD NOT BE INCREASED. THE HOSPITAL REPORTED THAT PRIMING WAS PERFORMED IN ACCORDANCE WITH THE STANDARD OPERATING PROCEDURE. PROVIDED VIDEOGRAPHIC EVIDENCE SHOWED AN OPERATING PUMP HEAD WITH AN INTERMITTENT SCRAPING NOISE. THE PATIENT LOST APPROXIMATELY 50 ML OF BLOOD AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS PROVIDED THAT STATED THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION DURING THIS EVENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.