XLUNG KIT 230
Received Jan 21, 2025 · Event occurred Jan 3, 2025
Report 3012172416-2025-00007 · MDR key 21199113
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXE1305
Product problems
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
Patient
NA · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4 PLANT INVESTIGATION: THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE AND/OR ON THE LABEL. DOCUMENTATION OF MODULE PRODUCTION SHOWED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. THE TREND ANALYSIS SHOWED ONE SIMILAR COMPLAINT UNDER THE SAME BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. DUE TO 100% LEAK TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. REPORTEDLY, THE LUER CAP WAS NOT CHANGED, HOWEVER, THE PHOTOS ARE NOT SHOWING THE ORIGINAL CAP 8200739BECAUSE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A DEFINITIVE CAUSE OF THE DESCRIBED LEAK COULD NOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION, A CRACK IN THE BLOOD SAMPLE PORT COULD HAVE CAUSED THE LEAK. MATERIAL STRESSES MAY OCCUR DURING THE INJECTION MOLDING PROCESS AND CRACKS CAN SUBSEQUENTLY BE CAUSED BY THE RELEASE OF MATERIAL STRESSES, FOR EXAMPLE, DURING HANDLING, E.G. TIGHTENING OF THE CONNECTION OR TRANSPORT. THE OXYGENATORS FOR THIS XLUNG KIT 230 CN WERE PRODUCED IN SEPTEMBER 2022. THE INJECTION MOLDING TOOL FOR THE OXYGENATOR HOUSING HAS BEEN REPLACED SINCE THEN WITH START OF PRODUCTION IN DECEMBER 2023.
Description of Event or Problem
A USER FACILITY REPORTED THAT A BLOOD SAMPLING PORT HAD A BLOOD LEAK FOLLOWING TWO HOURS OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT START. THE PHYSICIAN EXCHANGED OXYGENATORS RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THERE WAS NO INDICATION THE PATIENT EXPERIENCED A SERIOUS INJURY DUE TO THIS EVENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND NOT AVAILABLE FOR PRODUCT RETURN.
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 A BLOOD SAMPLING PORT HAD A BLOOD LEAK FOLLOWING TWO HOURS OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT START. THE PHYSICIAN EXCHANGED OXYGENATORS RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THERE WAS NO INDICATION THE PATIENT EXPERIENCED A SERIOUS INJURY DUE TO THIS EVENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND NOT AVAILABLE FOR PRODUCT RETURN.