IPS PRESSURE SENSOR CONNECTING CABLE
Received Feb 19, 2026 · Event occurred Feb 2, 2026
Report 3012172416-2026-00014 · MDR key 24387206
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
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 ON AN INTEGRATED PRESSURE SENSING (IPS) CONNECTING CABLE WITH PRESSURE SENSOR MALFUNCTION AND/OR BREAKAGE. THE USER STATED THE CONSOLE WAS READING PRESSURES THAT WERE OBVIOUSLY INCORRECT AND THEY NEEDED TO REPLACE IPS CABLE. THE USER STATED THE CABLE RELEASE BUTTON WOULD NOT DEPRESS, SO THEY HAD TO USE HEMOSTATS TO GET IT TO RELEASE FROM THE CIRCUIT. 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.
Description of Event or Problem
A USER FACILITY REPORTED ON AN INTEGRATED PRESSURE SENSING (IPS) CONNECTING CABLE WITH PRESSURE SENSOR MALFUNCTION AND/OR BREAKAGE. THE USER STATED THE CONSOLE WAS READING PRESSURES THAT WERE OBVIOUSLY INCORRECT AND THEY NEEDED TO REPLACE IPS CABLE. THE USER STATED THE CABLE RELEASE BUTTON WOULD NOT DEPRESS, SO THEY HAD TO USE HEMOSTATS TO GET IT TO RELEASE FROM THE CIRCUIT. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT RETURNED BY THE USER FACILITY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, H3, H4, H6 PLANT INVESTIGATION: NO NON-CONFORMITY WAS OBSERVED DURING THE MANUFACTURING PROCESS. ONE OTHER SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE SAMPLE WAS NOT RECEIVED, AND A PHYSICAL INVESTIGATION COULD NOT BE CARRIED OUT. A DEFECT IN THE CABLE OR CABLE CONNECTION MAY HAVE CAUSED THE ISSUE; HOWEVER, A DEFINITIVE CAUSE FOR THE DEFECT COULD NOT BE DETERMINED. IF THE SAMPLE IS RECEIVED ON A LATER DATE, THE COMPLAINT RECORD WILL BE RE-EVALUATED.