XLUNG KIT 230
Received Jan 30, 2025 · Event occurred Jan 9, 2025
Report 3012172416-2025-00012 · MDR key 21273201
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
8017146
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Fluid/Blood Leak
- Mechanical Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- 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 A BLOOD LEAK FROM THE TEMPERATURE PORT FOLLOWING 10 MINUTES AFTER THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE PHYSICIAN DETERMINED THAT THERE WAS A RISK OF INFECTION AND EXCHANGED TO A NEW KIT, RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THERE WAS NO PATIENT INJURY SPECIFIED. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4. PLANT INVESTIGATION: UPON BATCH REVIEW, NONCONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS AND NO QUALITY EVENTS REFER TO THE DESCRIBED FAILURE PATTERN IN THIS COMPLAINT. THE TREND ANALYSIS SHOWED NO OTHER COMPLAINTS THAT WERE REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. ALL OXYGENATORS ARE TESTED FOR LEAKAGES DURING PROCESS CONTROLS. DUE TO 100% LEAK TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. FURTHERMORE, NO OTHER COMPLAINTS REGARDING THIS ISSUE WERE REPORTED REGARDING THIS BATCH NUMBER; THEREFORE, A RETENTION SAMPLE ANALYSIS IS NOT DONE. BECAUSE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A DEFINITIVE CAUSE OF THE DESCRIBED LEAK COULD NOT BE DETERMINED. IT IS POSSIBLE THAT CRACKS MAY SUBSEQUENTLY OCCUR IN THE TEMPERATURE PORT DURING TRANSPORT OR HANDLING.
Description of Event or Problem
A USER FACILITY REPORTED A BLOOD LEAK FROM THE TEMPERATURE PORT FOLLOWING 10 MINUTES AFTER THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE PHYSICIAN DETERMINED THAT THERE WAS A RISK OF INFECTION AND EXCHANGED TO A NEW KIT, RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION. UPON FOLLOW-UP, IT WAS REPORTED THAT THE CONSOLE WAS ALSO EXCHANGED TO A COMPETITOR PRODUCT. THERE WAS NO RESULTING SERIOUS INJURY.