XLUNG KIT 230
Received Jul 11, 2025 · Event occurred Jun 16, 2025
Report 3012172416-2025-00066 · MDR key 22478167
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXB0305
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT FOLLOWING A VERY GOOD INITIAL POST-OXYGENATOR ARTERIAL BLOOD GAS, THE OXYGENATION PERFORMANCE OF THE XLUNG KIT 230 DETERIORATED QUICKLY WITHOUT DISCERNIBLE CAUSE. DURING SUPPORT, THE OXYGENATION PERFORMANCE OF THE KIT IMPROVED AND DETERIORATED AGAIN. THERE WAS NO RESULTING 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.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, H6. PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS OF BATCH. NO OTHER COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON REPORTED SUPPORT SETTINGS, AN ESTIMATED OXYGEN TRANSFER OF 171 ML/MIN WAS CALCULATED, WHICH IS WITHIN THE EXPECTED RANGE FOR A BLOOD FLOW OF 3.5 L/MIN. THE CALCULATED OXYGEN TRANSFER RATE OF APPROXIMATELY 171 ML O2/MIN WAS ADEQUATE FOR THE BLOOD FLOW AND HEMOGLOBIN LEVEL. TRANSIENT DROPS IN POST-OXYGENATOR ARTERIAL OXYGEN COULD BE EXPLAINED BY HEMODYNAMIC OR SAMPLING VARIABILITY RATHER THAN DEVICE MALFUNCTION. HOWEVER, DUE TO LACK OF PRODUCT INFORMATION AND UNAVAILABILITY OF THE COMPLAINT SAMPLE, A DEFINITIVE CAUSE FOR THE VARIATIONS IN POST-OXYGENATOR ARTERIAL OXYGEN VALUES COULD NOT BE DETERMINED.
Description of Event or Problem
A USER FACILITY REPORTED THAT FOLLOWING A VERY GOOD INITIAL POST-OXYGENATOR ARTERIAL BLOOD GAS, THE OXYGENATION PERFORMANCE OF THE XLUNG KIT 230 DETERIORATED QUICKLY WITHOUT DISCERNIBLE CAUSE. DURING SUPPORT, THE OXYGENATION PERFORMANCE OF THE KIT IMPROVED AND DETERIORATED AGAIN. THE PATIENT WAS ABLE TO CONTINUE SUPPORT WITH THIS XLUNG KIT 230. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.