XLUNG KIT 230
Received May 21, 2025 · Event occurred May 3, 2025
Report 3012172416-2025-00048 · MDR key 22060513
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
- Output Problem
- Insufficient Device Problem Information
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
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 ON THE 26TH OF APRIL, 2025, THE XLUNG KIT 230 WAS PRIMED ACCORDING TO STANDARD PROCESS. NO AIR WAS VISIBLE IN THE PUMP HEAD OR THE VENOUS BUBBLE TRAP OF THE OXYGENATOR. ON THE 3RD OF MAY, AROUND 19:15 (LOCAL), THERE WERE AUDIBLE CLACKING SOUNDS FROM THE PUMP HEAD. THE PUMP DRIVE WAS EXCHANGED BUT THIS DID NOT RESOLVE THE ISSUE, AND THE SOUND PERSISTED. THE PUMP HEAD SHOWED NO VISIBLE DEFECTS ON THE OUTSIDE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
H3 NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS FOR THIS BATCH NUMBER FOLLOW THE SAME FAILURE PATTERN. THE PUMP HEAD WAS RECEIVED FOR PRODUCT EVALUATION. THERE WAS NO GAP BETWEEN THE INNER HOUSING AND THE ROTOR WAS RUBBING ON THE INNER HOUSING DURING FUNCTIONAL TESTING. IT WAS FOUND THAT THE BALL BEARING IN THE ROTOR WAS DAMAGED AS THE CERAMIC BALL WAS SUNK INTO THE TIP OF THE ROTOR. CIRCULAR SCRATCH MARKS WERE VISIBLE ON THE BASE OF THE INNER HOUSING AND SCRATCHING WAS VISIBLE ON THE BASE OF THE ROTOR. THE TIP OF THE ROTOR WAS DEFORMED. THE PUMP HEAD WAS PROBABLY DAMAGED DURING OPERATION RESULTING IN THE DESCRIBED NOISE. SINCE THE BALL BEARING IS COOLED BY THE LIQUID FLOW IN THE PUMP HEAD, AN ACCUMULATION OF AIR IN THE PUMP HEAD CAN LEAD TO AN INTERRUPTION OF THE COOLING AND DAMAGE OF THE BEARING.
Description of Event or Problem
A USER FACILITY REPORTED THAT ON THE (B)(6) 2025, THE XLUNG KIT 230 WAS PRIMED ACCORDING TO STANDARD PROCESS. NO AIR WAS VISIBLE IN THE PUMP HEAD OR THE VENOUS BUBBLE TRAP OF THE OXYGENATOR. ON THE (B)(6), AROUND 19:15 (LOCAL), THERE WERE AUDIBLE CLACKING SOUNDS FROM THE PUMP HEAD. THE PUMP DRIVE WAS EXCHANGED BUT THIS DID NOT RESOLVE THE ISSUE, AND THE SOUND PERSISTED. THE PUMP HEAD SHOWED NO VISIBLE DEFECTS ON THE OUTSIDE. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AS THE PUMP HEAD WAS RETAINED FROM THE KIT.
Description of Event or Problem
A USER FACILITY REPORTED THAT ON THE (B)(6) 2025, THE XLUNG KIT 230 WAS PRIMED ACCORDING TO STANDARD PROCESS. NO AIR WAS VISIBLE IN THE PUMP HEAD OR THE VENOUS BUBBLE TRAP OF THE OXYGENATOR. ON THE (B)(6), AROUND 19:15 (LOCAL), THERE WERE AUDIBLE CLACKING SOUNDS FROM THE PUMP HEAD. THE PUMP DRIVE WAS EXCHANGED BUT THIS DID NOT RESOLVE THE ISSUE, AND THE SOUND PERSISTED. THE PUMP HEAD SHOWED NO VISIBLE DEFECTS ON THE OUTSIDE. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AS THE PUMP HEAD WAS RETAINED FROM THE KIT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, H3 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.