XLUNG KIT 230
Received Aug 15, 2025 · Event occurred Jul 30, 2025
Report 3012172416-2025-00079 · MDR key 22814005
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXL0405
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Defective Component
- Output Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Defective Component
- Output Problem
Patient
59 YR · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: SECTION A (ADDITIONAL PATIENT INFORMATION) 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 A PRESSURE SENSOR DEFECT. THE PATIENT HAD A BLOOD LOSS OF APPROXIMATELY 50 ML DUE TO KIT EXCHANGE. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4 PLANT INVESTIGATION: ONE SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER, AND A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO NON-CONFORMITY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A PHOTO WAS PROVIDED WHICH SHOWS AN INCREASING PRESSURE VALUE AT THE P2 PORT AND DELTA PRESSURE IN THE TREND TABLE OF THE CONSOLE. THE P3 VALUE REMAINED AT THE SAME LEVEL. EXCHANGING THE INTEGRATED PRESSURE SENSING (IPS) CONNECTING CABLE DID NOT SOLVE THE ISSUE. A DEFINITE CAUSE COULD NOT BE DETERMINED. IT IS ASSUMED THAT THERE WAS A DEFECT WITH THE P2 IPS CONNECTION PORT.
Description of Event or Problem
A USER FACILITY REPORTED A PRESSURE SENSOR DEFECT. THE PATIENT HAD A BLOOD LOSS OF APPROXIMATELY 50 ML DUE TO KIT EXCHANGE. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.
Description of Event or Problem
A USER FACILITY REPORTED A PRESSURE SENSOR DEFECT. THE PATIENT HAD A BLOOD LOSS OF APPROXIMATELY 50 ML DUE TO AN UNREPORTED CAUSE. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.