XLUNG KIT (USA)
Received Mar 17, 2025 · Event occurred Feb 28, 2025
Report 3012172416-2025-00026 · MDR key 21617764
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F32000004
Lot number
FSXC1111
Product problems
- Leak/Splash
- Mechanical Problem
- Leak/Splash
- Mechanical Problem
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- 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 THAT WHILE FILLING THE PRIMING BAG WITH FLUID, THEY NOTICED FLUID LEAKING FROM THE PRIMING BAG WHERE THE BAG MEETS THE TUBING SEAL. PHOTOGRAPHIC EVIDENCE SHOWED A BREAKAGE IN THE BAG AROUND THE COLLAR OF THE TUBING CONNECTION. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE AND A SHIP KIT HAS BEEN SENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D3, D4, D9, G1, H3 PLANT INVESTIGATION: NO NON-CONFORMITY WAS OBSERVED DURING MANUFACTURING PROCESS. COMPLAINTS FOR THIS BATCH NUMBER DID NOT FOLLOW THE SAME FAILURE PATTERN. A SAMPLE WAS RECEIVED FROM THE REPORTED LOT NUMBER. THE SAMPLE WAS RETURNED COMPLETELY IN OPENED PACKAGING. THERE WERE TWO CUTS IN THE PRIMING BAG WITHIN PROXIMITY TO EACH OTHER; BOTH CUTS HAD SMOOTH EDGES. OF THE TWO CUTS, ONE CUT IS LOCATED WHERE THE TUBING CONNECTS TO THE BAG AND OTHER CUT IS ON THE BAG FILM AND TOUCHES THE WELD TO THE TUBING. UNDER MAGNIFICATION, THE CUT ON THE TUBING MEASURED APPROXIMATELY 4.12 MM IN LENGTH AND THE CUT ON THE BAG FILM MEASURED APPROXIMATELY 9.43 MM IN LENGTH. NO OTHER DAMAGE OR IRREGULARITIES WERE NOTED. THE PROBABLE CAUSE OF THIS DAMAGE IS DUE TO A HANDLING ISSUE DURING THE ASSEMBLY PROCESS. AS THE DAMAGE WAS FOUND ON THE COMPONENT, THE PROBABLE CAUSE WAS TRACED TO A COMPONENT FAILURE.
Description of Event or Problem
A USER FACILITY REPORTED THAT WHILE FILLING THE PRIMING BAG WITH FLUID, THEY NOTICED FLUID LEAKING FROM THE PRIMING BAG WHERE THE BAG MEETS THE TUBING SEAL. PHOTOGRAPHIC EVIDENCE SHOWED A BREAKAGE IN THE BAG AROUND THE COLLAR OF THE TUBING CONNECTION. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO NON-CONFORMITY WAS OBSERVED DURING MANUFACTURING PROCESS. COMPLAINTS FOR THIS BATCH NUMBER DID NOT FOLLOW THE SAME FAILURE PATTERN. A SAMPLE WAS RECEIVED FROM THE REPORTED LOT NUMBER. THE SAMPLE WAS RETURNED COMPLETELY IN OPENED PACKAGING. THERE WERE TWO CUTS IN THE PRIMING BAG WITHIN PROXIMITY TO EACH OTHER; BOTH CUTS HAD SMOOTH EDGES. OF THE TWO CUTS, ONE CUT IS LOCATED WHERE THE TUBING CONNECTS TO THE BAG AND OTHER CUT IS ON THE BAG FILM AND TOUCHES THE WELD TO THE TUBING. UNDER MAGNIFICATION, THE CUT ON THE TUBING MEASURED APPROXIMATELY 4.12 MM IN LENGTH AND THE CUT ON THE BAG FILM MEASURED APPROXIMATELY 9.43 MM IN LENGTH. NO OTHER DAMAGE OR IRREGULARITIES WERE NOTED. THE PROBABLE CAUSE OF THIS DAMAGE IS DUE TO A HANDLING ISSUE DURING THE ASSEMBLY PROCESS. AS THE DAMAGE WAS FOUND ON THE COMPONENT, THE PROBABLE CAUSE WAS TRACED TO A COMPONENT FAILURE.
Description of Event or Problem
A USER FACILITY REPORTED THAT WHILE FILLING THE PRIMING BAG WITH FLUID, THEY NOTICED FLUID LEAKING FROM THE PRIMING BAG WHERE THE BAG MEETS THE TUBING SEAL. PHOTOGRAPHIC EVIDENCE SHOWED A BREAKAGE IN THE BAG AROUND THE COLLAR OF THE TUBING CONNECTION. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.