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XLUNG KIT 230

Received Apr 24, 2025 · Event occurred Apr 10, 2025

Report 3012172416-2025-00037 · MDR key 21899089

Device

Generic name

Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure

Manufacturer

Xenios Ag

Catalog number

32000014

Lot number

FSXD0810

Product problems

  • Leak/Splash
  • Mechanical Problem
  • Leak/Splash
  • Mechanical Problem

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 AS SOON AS THE MEMBRANE WAS DE-AIRED, THE PERFUSIONIST NOTICED DROPS OF FLUID ON THE FLOOR AND SAW THE MEMBRANE LEAKING. UPON FURTHER INVESTIGATION, THE USER FOUND THE LEAKAGE AT THE TEMPERATURE PORT. THE USER TOUCHED THE TEMPERATURE PORT AND IT WAS LOOSE. THE USER ATTEMPTED TO TIGHTEN THE PORT INTO THE MEMBRANE WITH A CLAMP BUT THE LEAK PERSISTED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT AS SOON AS THE MEMBRANE WAS DE-AIRED, THE PERFUSIONIST NOTICED DROPS OF FLUID ON THE FLOOR AND SAW THE MEMBRANE LEAKING. UPON FURTHER INVESTIGATION, THE USER FOUND THE LEAKAGE AT THE TEMPERATURE PORT. THE USER TOUCHED THE TEMPERATURE PORT AND IT WAS LOOSE. THE USER ATTEMPTED TO TIGHTEN THE PORT INTO THE MEMBRANE WITH A CLAMP BUT THE LEAK PERSISTED. AN ADDITIONAL KIT WAS PRIMED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, H3 PLANT INVESTIGATION: REVIEW OF BATCH INFORMATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS RELATED TO THE OBSERVED FAILURE. TREND ANALYSIS SHOWED SIMILAR COMPLAINTS WITH THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON APRIL 23, 2025. A LEAKAGE TEST REVEALED A LIQUID LEAK COMING FROM THE RECIRCULATION PORT OF THE OXYGENATOR. THERE WAS NO VISIBLE DAMAGE TO THE RECIRCULATION PORT OR AT THE LUER ADAPTER OF THE ARTERIAL VENTING LINE. NO LEAK WAS DETECTED AT THE TEMPERATURE PORT. THE CAUSE OF A POSSIBLE LEAK AT THIS LOCATION HAS BEEN IDENTIFIED. IT WAS FOUND THAT A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT RESULTS IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. THIS DEVIATION WAS CORRECTED AND A CAPA WAS ESTABLISHED TO ADDRESS THE ISSUE.

Description of Event or Problem

A USER FACILITY REPORTED THAT AS SOON AS THE MEMBRANE WAS DE-AIRED, THE PERFUSIONIST NOTICED DROPS OF FLUID ON THE FLOOR AND SAW THE MEMBRANE LEAKING. UPON FURTHER INVESTIGATION, THE USER FOUND THE LEAKAGE AT THE TEMPERATURE PORT. THE USER TOUCHED THE TEMPERATURE PORT AND IT WAS LOOSE. THE USER ATTEMPTED TO TIGHTEN THE PORT INTO THE MEMBRANE WITH A CLAMP BUT THE LEAK PERSISTED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.