IPS PRESSURE SENSOR CONNECTING CABLE
Received Feb 27, 2026 · Event occurred Feb 7, 2026
Report 3012172416-2026-00015 · MDR key 24468616
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F38350001
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
Description of Event or Problem
A USER FACILITY REPORTED ON A PATIENT PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT WITH THE NOVALUNG CONSOLE. THE P1 PRESSURE DID NOT MAKE SENSE CLINICALLY AT +433. THE INTEGRATED PRESSURE SENSING CONNECTING CABLE WAS REPLACED AND MEASUREMENT WENT TO -50. THE ORIGINAL CABLE WAS SUSPECTED OF BEING DAMAGED. THE CABLE WAS TESTED BY MOVING TO P3 TO ASSESS IT'S ACCURACY AND P3 MEASUREMENT CHANGED FROM 132 WITH IT'S ORIGINAL CABLE TO 437 WITH THE CABLE THAT HAD BEEN IN P1. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AND A SHIP KIT HAS BEEN SENT TO THE FACILITY.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.