XLUNG KIT 230
Received Feb 28, 2025 · Event occurred Jan 30, 2025
Report 3012172416-2025-00023 · MDR key 21490274
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
8016908
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Fluid/Blood Leak
- Mechanical Problem
Patient
NA · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT BOTH A TEMPERATURE PORT AND BLOOD SAMPLE PORT HAD BLOOD LEAKS AFTER ONE HOUR OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE PHYSICIAN ATTEMPTED TO TIGHTEN THE CONNECTION TO NO AVAIL. 3M TAPE WAS UTILIZED TO BLOCK THE PORTS. THE PATIENT'S TOTAL BLOOD LOSS WAS APPROXIMATED AT 10 TO 20 ML OF BLOOD. THERE WAS NO RESULTING PATIENT INJURY. THE COMPLAINT SAMPLE WAS NO AVAILABLE FOR PRODUCT INVESTIGATION.
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 BOTH A TEMPERATURE PORT AND BLOOD SAMPLE PORT HAD BLOOD LEAKS AFTER ONE HOUR OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE PHYSICIAN ATTEMPTED TO TIGHTEN THE CONNECTION TO NO AVAIL. 3M TAPE WAS UTILIZED TO BLOCK THE LEAK. THE PATIENT'S TOTAL BLOOD LOSS WAS APPROXIMATED AT 10 TO 20 ML OF BLOOD. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION. UPON FOLLOW-UP, IT WAS REPORTED THE PATIENT CONTINUED ON ECMO SUPPORT UTILIZING THE SAME XLUNG KIT 230 WITHOUT INCIDENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. ONE SIMILAR COMPLAINT HAS BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. DUE TO 100% TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. A DEFINITIVE CAUSE OF THE DESCRIBED LEAK COULD NOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION, A CRACK IN THE BLOOD SAMPLING PORT COULD HAVE CAUSED THE LEAK. MATERIAL STRESS MAY OCCUR DURING THE INJECTION MOLDING PROCESS AND CRACKS CAN SUBSEQUENTLY BE CAUSED BY THE RELEASE OF MATERIAL STRESS DURING HANDLING, E.G. TIGHTENING OF THE CONNECTION OR TRANSPORT. THE OXYGENATORS FOR THIS XLUNG KIT 230 CN WERE PRODUCED FROM JULY 2022 TO SEP.2022. THE INJECTION MOLDING TOOL FOR THE OXYGENATOR HOUSING HAS BEEN REPLACED SINCE THEN.