IPS PRESSURE SENSOR CONNECTING CABLE
Received May 8, 2026 · Event occurred Mar 24, 2026
Report 3012172416-2026-00034 · MDR key 25122127
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 THAT THERE WAS AN ISSUE WITH THE INTEGRATED PRESSURE SENSING CONNECTING CABLES UTILIZED WITH THE NOVALUNG EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) MACHINE BY FRESENIUS MEDICAL. THE USER FACILITY STATED THEY HAVE HAD AN ADDITIONAL THREE CABLE FAILURES IN THE LAST MONTH. THE MOST RECENT BEING LAST NIGHT. THE USER FACILITY REPORTED THAT NOT ONLY IS THE PRODUCT FAILING BUT READING VERY INCORRECT VALUES, POTENTIALLY LEADING TO INCORRECT TREATMENT OF THE PATIENT. THIS IS RELATED TO PART NUMBER 3835001 WITH LOT NUMBERS: FSXF2421, GSXA2422, FSXI0401.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.