XLUNG KIT (USA)
Received Mar 26, 2026 · Event occurred Mar 5, 2026
Report 3012172416-2026-00026 · MDR key 24698391
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F32000004
Lot number
GSXK1302
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- 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 THE P3 SENSOR STARTED READING ABNORMAL PRESSURE READINGS THAT WENT INTO NEGATIVE NUMBERS. THE USER SWITCHED CABLES WITH NO RESOLUTION. THE USER THEN MONITORED PRESSURES USING AN EXTERNAL PRESSURE SENSOR. THE CLINICAL SPECIALIST PERFORMED TROUBLESHOOTING ONSITE WITHIN THEIR SCOPE AND MADE THE DECISION TO APPLY EXTERNAL PRESSURE MONITORING. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.