inforMED
MalfunctionQJZ

XLUNG KIT (USA)

Received Sep 12, 2025 · Event occurred Aug 28, 2025

Report 3012172416-2025-00095 · MDR key 23036720

Device

Generic name

Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure

Manufacturer

Xenios Ag

Catalog number

F32000004

Lot number

FSXC1111

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

Description of Event or Problem

A USER FACILITY REPORTED A PRE-OXYGENATOR PORT LEAKING DURING WET PRIME AND UNABLE TO BE RESOLVED. A PERFUSIONIST SALINE PRIMED THE XLUNG KIT AND FOUND AS SOON AS THE KIT WAS PLACED UNDER PRESSURE, THE PRE-OXYGENATOR PORT WAS LEAKING. THEY CONFIRMED SECURE ATTACHMENT OF THE PIGTAIL WITH NO RESOLUTION AND THEN TRIED CHANGING TO A NEW PIGTAIL WITH NO RESOLUTION. FLUID APPEARED TO BE LEAKING FROM THE PORT ITSELF. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3. PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING MANUFACTURING PROCESS. SIMILAR COMPLAINTS CONCERNING LUER ADAPTOR AND RECIRCULATION PORT BREAKAGES HAVE BEEN REPORTED; HOWEVER, NO OTHER COMPLAINTS HAVE BEEN RECEIVED ABOUT THIS BATCH NUMBER. THE SAMPLE WAS RECEIVED ON OCTOBER 6, 2025. THE SAMPLE ARRIVED WITHOUT A LINE OR CONNECTOR ATTACHED TO THE RECIRCULATION PORT OF THE OXYGENATOR. IT WAS FOUND THAT THE INNER CONE OF THE LUER ADAPTER WHICH HAD BEEN PREVIOUSLY ATTACHED TO THE RECIRCULATION PORT HAD BROKEN OFF, AND THE PART WAS STUCK INSIDE THE PORT. NO DEFECT WAS FOUND AT THE LUER CONNECTION OF THE VENOUS VENTING PORT. THE PORT AND THE CONNECTED LUER ADAPTER WERE INTACT. THE CONE WAS REMOVED FROM THE TEMPERATURE PORT AND A LEAK TEST WAS PERFORMED. NO LEAK WAS DETECTED AT THE RECIRCULATION PORT. HOWEVER, A LEAK WAS DETECTED AT THE TEMPERATURE PORT WHICH WAS CAUSED BY A CRACK IN THE PORT. ALL OXYGENATORS ARE TESTED FOR LEAKAGES DURING PROCESS CONTROLS. IT IS POSSIBLE THAT CRACKS MAY SUBSEQUENTLY OCCUR IN THE TEMPERATURE PORT DURING TRANSPORT OR HANDLING.

Description of Event or Problem

A USER FACILITY REPORTED A PRE-OXYGENATOR PORT LEAKING DURING WET PRIME AND UNABLE TO BE RESOLVED. A PERFUSIONIST SALINE PRIMED THE XLUNG KIT AND FOUND AS SOON AS THE KIT WAS PLACED UNDER PRESSURE, THE PRE-OXYGENATOR PORT WAS LEAKING. THEY CONFIRMED SECURE ATTACHMENT OF THE PIGTAIL WITH NO RESOLUTION AND THEN TRIED CHANGING TO A NEW PIGTAIL WITH NO RESOLUTION. FLUID APPEARED TO BE LEAKING FROM THE PORT ITSELF. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION AND A SHIP-KIT HAS BEEN SENT.

Additional Manufacturer Narrative

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