inforMED
MalfunctionQJZ

XLUNG KIT (USA)

Received Dec 11, 2025 · Event occurred Nov 25, 2025

Report 3012172416-2025-00113 · MDR key 23776927

Device

Generic name

Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure

Manufacturer

Xenios Ag

Catalog number

F32000004

Lot number

FSXF0312

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • Output Problem
  • Insufficient Device Problem Information
  • Incorrect, Inadequate or Imprecise Result or Readings
  • Output Problem
  • Insufficient Device Problem Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3, H6 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED ONSITE. THE RETAINED SAMPLE OF BATCH FSXF0312 WAS TESTED FOR FUNCTIONALITY OF THE INTEGRATED PRESSURE SENSORS, AND IT WAS DETERMINED THAT ALL THREE SENSORS FUNCTIONED AS INTENDED.

Description of Event or Problem

A USER FACILITY EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) COORDINATOR REACHED OUT TO REQUEST ASSISTANCE WITH TROUBLESHOOTING A "P3 TECHNICAL FAILURE" ALARM THAT HAD BEEN REOCCURRING THROUGHOUT THE SHIFT. THE USER ATTEMPTED TROUBLESHOOTING BY CHANGING THE PRESSURE CABLE WHICH WAS UNSUCCESSFUL. THE PROBLEM APPEARED TO BE WITH P3 INTEGRATED PRESSURE SENSOR ON THE XLUNG KIT. THE USER WAS UNABLE TO CONFIRM WHETHER FLUID AFFECTED THE MEASUREMENT. THE CABLE WAS REMOVED AND AN ALARM RESET WAS PERFORMED. THE PATIENT CONTINUED ECMO SUPPORT WITH THE SAME KIT AND NO P3 MEASUREMENT. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION; HOWEVER, IT WAS NOT RECEIVED FORM THE REPORTING FACILITY.

Description of Event or Problem

A USER FACILITY EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) COORDINATOR REACHED OUT TO REQUEST ASSISTANCE WITH TROUBLESHOOTING A "P3 TECHNICAL FAILURE" ALARM THAT HAD BEEN REOCCURRING THROUGHOUT THE SHIFT. THE USER ATTEMPTED TROUBLESHOOTING BY CHANGING THE PRESSURE CABLE WHICH WAS UNSUCCESSFUL. THE PROBLEM APPEARED TO BE WITH P3 INTEGRATED PRESSURE SENSOR ON THE XLUNG KIT. THE USER WAS UNABLE TO CONFIRM WHETHER FLUID AFFECTED THE MEASUREMENT. THE CABLE WAS REMOVED AND AN ALARM RESET WAS PERFORMED. THE PATIENT CONTINUED ECMO SUPPORT WITH THE SAME KIT AND NO P3 MEASUREMENT. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

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