XLUNG KIT 230
Received Sep 12, 2025 · Event occurred Aug 24, 2025
Report 3012172416-2025-00094 · MDR key 23036545
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXL1111
Product problems
- Infusion or Flow Problem
- Air/Gas in Device
- Infusion or Flow Problem
- Air/Gas in Device
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A COUNTRY COMPLAINT ADMINISTRATOR (CCA) RECEIVED CUSTOMER FEEDBACK REGARDING A DESIGN CHANGE IN THE XLUNG KIT 230 WASTE LIQUID BAG, WHERE THE DISTANCE BETWEEN THE INLET AND OUTLET TUBES HAVE BEEN REDUCED COMPARED TO THE PREVIOUS DESIGN. CUSTOMER FEEDBACK STATED AIR EXHAUSTION DIFFICULTIES THAT OCCURRED UNDER THE CLINICAL STANDARD OPERATION (PLEASE REFER TO VIDEO 1) AND EVEN AIR BUBBLES RE-ENTERING THE PUMP HEAD HAVE BEEN OBSERVED, POSING RISKS TO CLINICAL TREATMENT AND POTENTIALLY DAMAGING THE PUMP HEAD (PLEASE REFER TO VIDEO 2). UNTIL NOW, THE CCA RECEIVED THREE SIMILAR CASES CONCERNING DIFFERENT BATCH NUMBERS AND DIFFERENT HOSPITALS. THE CCA REPORTED THAT THIS COMPLAINT WAS THE SECOND CASE.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, H6. PLANT INVESTIGATION: NONCONFORMITY OBSERVED DURING THE MANUFACTURING PROCESS IS NOT RELATED TO THIS COMPLAINT. ONE OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER BUT DOES NOT FOLLOW THE SAME FAILURE PATTERN. THE COMPLAINT SAMPLE WAS NOT RECEIVED. THE PRIMING SET WAS CHANGED (DEHP-FREE PRIMING BAG) IN APRIL 2024 WHICH INVOLVED INCREASING THE CAPACITY OF THE PRIMING BAG FROM 1300 ML TO 1500 ML. THE CAUSE WAS TRACED TO UNINTENDED USER ERROR.
Description of Event or Problem
A COUNTRY COMPLAINT ADMINISTRATOR (CCA) RECEIVED CUSTOMER FEEDBACK REGARDING A DESIGN CHANGE IN THE XLUNG KIT 230 WASTE LIQUID BAG, WHERE THE DISTANCE BETWEEN THE INLET AND OUTLET TUBES HAVE BEEN REDUCED COMPARED TO THE PREVIOUS DESIGN. CUSTOMER FEEDBACK STATED AIR EXHAUSTION DIFFICULTIES THAT OCCURRED UNDER THE CLINICAL STANDARD OPERATION AND EVEN AIR BUBBLES RE-ENTERING THE PUMP HEAD HAVE BEEN OBSERVED, POSING RISKS TO CLINICAL TREATMENT AND POTENTIALLY DAMAGING THE PUMP HEAD. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION. THE CCA INITIALLY REPORTED THREE CASES; HOWEVER, IT WAS DETERMINED ONLY TWO CASES FOLLOW THE SAME ERROR PATTERN.