XLUNG KIT 230
Received May 22, 2025 · Event occurred Apr 19, 2025
Report 3012172416-2025-00049 · MDR key 22071158
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXK2802
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
Description of Event or Problem
A USER FACILITY REPORTED THAT, ON (B)(6) 2025, AT APPROXIMATELY 4:00 AM (LOCAL), A PERFUSIONIST PRIMED AN XLUNG CIRCUIT. UPON PRIMING THEY NOTICED THE IMPELLER IN THE CONE WAS WOBBLY. THEY INCREASED THE RPMS AND THE IMPELLER SPUN FASTER BUT REMAINED WOBBLY. THE CIRCUIT WAS TESTED WITH TWO DIFFERENT PUMPS TO MAKE SURE THAT THE PROBLEM IS THE ACTUAL PUMP HEAD AND NOT THE MACHINE OR PUMP DRIVE. THE IMPELLER REMAINED WOBBLY WITH BOTH PUMPS AND ANOTHER MACHINE. THE PATIENT CIRCUIT WAS EXCHANGED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RETURNED TO XENIOS FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D3, D4, D9, G1. PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED REGARDING THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED FOR INVESTIGATION ON MAY 30, 2025. THERE WAS NO VISIBLE DAMAGE TO THE PUMP HEAD. FUNCTIONAL TESTING REVEALED A SLIGHTLY UNEVEN RUN AT LOW SPEED UNTIL AROUND 4000 RPM. A LOUDER RUNNING NOISE WAS NOTICEABLE FROM AROUND 8200 RPM AND INCREASED TO 10,000 RPM. VISUAL INSPECTION SHOWED THAT THE MAGNET HAD A SLIGHT CURVATURE OUT OF THE ROTOR, AND AN UNEVENNESS WAS VISIBLE AT THE OUTER EDGE OF THE ROTOR. THE ISSUE IS ATTRIBUTED TO AN ERROR DURING THE ASSEMBLY PROCESS AND IS MOST LIKELY DUE TO A FAILURE OF THE ASSEMBLY PERSONNEL.
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 19/APR/2025 AT APPROXIMATELY 4:00 AM (LOCAL), A PERFUSIONIST PRIMED AN XLUNG CIRCUIT. UPON PRIMING THEY NOTICED THE IMPELLER IN THE CONE WAS WOBBLY. THEY INCREASED THE RPMS AND THE IMPELLER SPUN FASTER BUT REMAINED WOBBLY. THE CIRCUIT WAS TESTED WITH TWO DIFFERENT PUMPS TO MAKE SURE THAT THE PROBLEM IS THE ACTUAL PUMP HEAD AND NOT THE MACHINE OR PUMP DRIVE. THE IMPELLER REMAINED WOBBLY WITH BOTH PUMPS AND ANOTHER MACHINE. THE PATIENT CIRCUIT WAS EXCHANGED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.