XLUNG KIT 230
Received Nov 4, 2025 · Event occurred Oct 15, 2025
Report 3012172416-2025-00106 · MDR key 23464367
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXA2206
Product problems
- Contamination
- Contamination /Decontamination Problem
- Device Contaminated During Manufacture or Shipping
- Contamination
- Contamination /Decontamination Problem
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT DURING PREPARATION FOR AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ASSISTED SURGERY AT THE LUNG CENTER OF THE PHILIPPINES ON (B)(6) 2025, A WHITE FLOATING MATERIAL WAS OBSERVED WITHIN THE MEMBRANE AREA OF THE OXYGENATOR AFTER CIRCUIT PRIMING. THE ECMO CIRCUIT WAS A CLINICALLY SUPPLIED UNIT FROM DUBBEL MEDICAL CORP, INTENDED FOR ACTUAL PATIENT USE. THE MATERIAL APPEARED TO BE FREELY MOBILE INSIDE THE OXYGENATOR AND COULD NOT BE IDENTIFIED AS PART OF THE ORIGINAL MEMBRANE OR STRUCTURE. DUE TO CONCERN FOR POSSIBLE CONTAMINATION OR RISK OF EMBOLIZATION TO A PATIENT¿S CIRCULATION, THE CIRCUIT WAS DISCARDED AND UNAVAILABLE FOR PRODUCT INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, H6 PLANT INVESTIGATION: NO SIMILAR COMPLAINTS HAVE BEEN REPORTED IN THE PAST TWO YEARS. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THIS BATCH NUMBER REVEALED NO DEVIATIONS OR IRREGULARITIES RELATED TO THE DESCRIBED ISSUE. A SIMULATION TO REPRODUCE THE OBSERVED BEHAVIOR SHOWED THAT AN EXTERNAL PARTICLE INTRODUCED VIA THE BLOOD INLET CAN BECOME TEMPORARILY TRAPPED IN THE UPPER CYLINDRICAL REGION OF THE OXYGENATOR. BASED ON THE AVAILABLE INFORMATION, WE CANNOT CONCLUSIVELY DETERMINE THE ORIGIN OF THE PARTICLE. WE HAVE NOT IDENTIFIED ANY BATCH-RELATED PROBLEM AND ASSUME THAT THIS IS AN ISOLATED CASE.
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 DURING PREPARATION FOR AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ASSISTED SURGERY AT THE LUNG CENTER OF THE PHILIPPINES ON (B)(6) 2025, A WHITE FLOATING MATERIAL WAS OBSERVED WITHIN THE MEMBRANE AREA OF THE OXYGENATOR AFTER CIRCUIT PRIMING. THE ECMO CIRCUIT WAS A CLINICALLY SUPPLIED UNIT FROM DUBBEL MEDICAL CORP, INTENDED FOR ACTUAL PATIENT USE. THE MATERIAL APPEARED TO BE FREELY MOBILE INSIDE THE OXYGENATOR AND COULD NOT BE IDENTIFIED AS PART OF THE ORIGINAL MEMBRANE OR STRUCTURE. DUE TO CONCERN FOR POSSIBLE CONTAMINATION OR RISK OF EMBOLIZATION TO THE PATIENT¿S CIRCULATION, THE CIRCUIT WAS DISCARDED AND UNAVAILABLE FOR PRODUCT INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT.