XLUNG KIT 230
Received Sep 23, 2025 · Event occurred Aug 30, 2025
Report 3012172416-2025-00097 · MDR key 23127293
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXA0602
Product problems
- Contamination
- Contamination /Decontamination Problem
- Device Contaminated During Manufacture or Shipping
- Contamination
- Contamination /Decontamination Problem
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9 PLANT INVESTIGATION: NON-CONFORMITY REPORTED DURING PRODUCTION DID NOT FOLLOW THE SAME FAILURE PATTERN. NO OTHER SIMILAR COMPLAINTS GAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON SEPTEMBER 19, 2025. THE DESCRIBED BLACK DOTS AND AN ADDITIONAL RED MARK WERE FOUND ON THE TUBE IN THE TABLE TRAY. THESE WERE FOUND TO BE ON THE OUTSIDE OF THE TUBE. THE BLACK SPOTS COULD BE WIPED AWAY WITH A PAPER TOWEL SOAKED IN 70% ISOPROPYL ALCOHOL. THE RED MARK WAS NOT REMOVABLE AND MAY HAVE BEEN MADE WITH A PERMANENT MARKER. THE CAUSE WAS TRACED TO MANUFACTURING AND EMPLOYEES WERE MADE AWARE OF THIS ERROR PATTERN.
Description of Event or Problem
A USER FACILITY REPORTED THAT THEY DETECTED AT LEAST 5 BLACK DOTS ON THE PRODUCT, INDICATING CONTAMINATION IN THE STERILE PACKAGING OF THE XLUNG KIT. GIVEN THAT THIS UNIT COULD NOT BE DISASSEMBLED THE USER COULD NOT DETERMINE WHETHER THE CONTAMINATION IS ON THE OUTSIDE OR INSIDE OF THE TUBING SYSTEM, AND THEREFORE THE PRODUCT COULD NOT BE USED. THE USER DETECTED THE PROBLEM WHILE THE PRIMING FLUID WAS CIRCULATING, SO A MINIMAL AMOUNT OF PRIMING FLUID REMAINED IN THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT INVESTIGATION.
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 THEY DETECTED AT LEAST 5 BLACK DOTS ON THE PRODUCT, INDICATING CONTAMINATION IN THE STERILE PACKAGING OF THE XLUNG KIT. GIVEN THAT THIS UNIT COULD NOT BE DISASSEMBLED THE USER COULD NOT DETERMINE WHETHER THE CONTAMINATION IS ON THE OUTSIDE OR INSIDE OF THE TUBING SYSTEM, AND THEREFORE THE PRODUCT COULD NOT BE USED. THE USER DETECTED THE PROBLEM WHILE THE PRIMING FLUID WAS CIRCULATING, SO A MINIMAL AMOUNT OF PRIMING FLUID REMAINED IN THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.