XLUNG KIT 230
Received Aug 12, 2025 · Event occurred Jul 27, 2025
Report 3012172416-2025-00077 · MDR key 22781886
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Noise, Audible
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Noise, Audible
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- No Clinical Signs, Symptoms or Conditions
- Hemorrhage/Blood Loss/Bleeding
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5. PLANT INVESTIGATION: THE BATCH OF THE DISPOSABLE KIT IS UNKNOWN AND, THEREFORE, NO MANUFACTURING OR TRENDING REVIEW WAS PERFORMED FOR A SPECIFIC LOT NUMBER. THE LOG FILES OF THE CONSOLE WERE PROVIDED. THE AFFECTED XLUNG KIT 230 WAS NOT AVAILABLE FOR EVALUATION. THE MACHINE FILES SHOWED AN INCREASE OF THE POWER CONSUMPTION OF THE PUMP DRIVE ON (B)(6) 2025, WHICH COULD BE RELATED TO PUMP HEAD THROMBOSIS AND/OR DAMAGE OF THE PUMP HEAD. HOWEVER, SINCE THE PUMP HEAD COULD NOT BE INVESTIGATED, DEFINITIVE CAUSE COULD NOT BE CONFIRMED.
Description of Event or Problem
A USER FACILITY REPORTED AN ABNORMAL NOISE FROM THE PUMP DRIVE/PUMP HEAD AT HIGHER RPMS. THE ISSUE INVOLVES THE XENIOS CONSOLE WHICH IS GENERATING UNUSUALLY HIGH NOISE FROM THE PUMP DRIVE/PUMP HEAD DURING OPERATION AT HIGH RPMS. THIS ABNORMAL SOUND RAISED CONCERN WITH HOSPITAL STAFF (EXTRACORPOREAL MEMBRANE OXYGENATION SPECIALISTS, NURSES, DOCTORS). THE PATIENT REQUIRES HIGHER FLOW, NECESSITATING AN INCREASE IN RPM. SINCE THE TEAM MEMBERS WERE UNABLE TO TOLERATE THE SOUND, THEY PERFORMED A CIRCUIT EXCHANGE RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML AND ANOTHER PRIMED CIRCUIT WAS USED ON THE PATIENT WHICH SOLVED THE ISSUE OF THE ABNORMAL SOUND. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND NOT AVAILABLE 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 AN ABNORMAL NOISE FROM THE PUMP DRIVE/PUMP HEAD AT HIGHER RPMS. THE ISSUE INVOLVES THE XENIOS CONSOLE WHICH IS GENERATING UNUSUALLY HIGH NOISE FROM THE PUMP DRIVE/PUMP HEAD DURING OPERATION AT HIGH RPMS. THIS ABNORMAL SOUND RAISED CONCERN WITH HOSPITAL STAFF (EXTRACORPOREAL MEMBRANE OXYGENATION SPECIALISTS, NURSES, DOCTORS). THE PATIENT REQUIRES HIGHER FLOW, NECESSITATING AN INCREASE IN RPM. SINCE THE TEAM MEMBERS WERE UNABLE TO TOLERATE THE SOUND, THEY PERFORMED A CIRCUIT EXCHANGE RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML AND ANOTHER PRIMED CIRCUIT WAS USED ON THE PATIENT WHICH SOLVED THE ISSUE OF THE ABNORMAL SOUND. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.