XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR A PATIENT WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) ON VENO-VENOUS ECMO SUPPORT SINCE THE (B)(6) 2025, THIS PATIENT REQUIRED A SYSTEM CHANGE ON THE 27TH OF NOVEMBER FOLLOWING CLOTTING ON AN UNKNOWN DEVICE. THE PATIENT WAS ON THE XLUNG KIT 230 AFTERWARDS WITH A BLOOD FLOW OF 3 L/MIN. THERE WAS A DECLINE IN OXYGENATION LEADING TO THE NEED TO INCREASE BLOOD FLOW TO 6 L/MIN AND 100% FIO2 INCLUDING 20 PPM INHALED NITRIC OXIDE, WHICH RESULTED IN SATISFACTORY OXYGENATION. THERE WAS NO INDICATION OF RESULTING SERIOUS PATIENT INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, H6 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE BATCH OF THE PRODUCT IS UNKNOWN, AND NO FURTHER DETAILS WERE PROVIDED. AS A PHYSICAL EVALUATION COULD NOT BE CARRIED OUT, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. THE CAUSE FOR LOW POST-OXYGENATOR PARTIAL PRESSURE OF OXYGEN (PAO2) OR LOW OXYGENATOR PERFORMANCE CAN BE PRODUCT AS WELL AS APPLICATION/PATIENT RELATED. A FAILURE IN THE GAS EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL OR FURTHER PROCESSING DURING THE MANUFACTURING OF THE OXYGENATOR. ADDITIONALLY, THE PERFORMANCE OF THE GAS EXCHANGER IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION (ACT, APTT), BLOOD FLOW, SWEEP GAS FLOW, AND FIO2. CLOTTING OF THE OXYGENATOR CAN NEGATIVELY IMPACT GAS EXCHANGE. ADDITIONALLY, HIGH BLOOD LEVELS OF FATS (HIGH SERUM LIPID LEVELS, E.G. AS A RESULT OF INTRAVENOUS NUTRITION (WITH LIPIDS) OR SEDATION WITH PROPOFOL) OR HIGH FIBRINOGEN CAN LEAD TO SECONDARY MEMBRANE FORMATION IN THE OXYGENATOR WHICH MAY RESULT IN IMPAIRED GAS EXCHANGE. DUE TO THE INCREASED NUMBER OF COMPLAINTS DESCRIBING A LOW POST-OXYGENATOR PAO2 VALUE, A QUALITY EVENT WAS OPENED FOR FURTHER INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR A PATIENT WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) ON VENO-VENOUS ECMO SUPPORT SINCE THE (B)(6) 2025, THIS PATIENT REQUIRED A SYSTEM CHANGE ON THE (B)(6) FOLLOWING CLOTTING ON AN UNKNOWN DEVICE. THE PATIENT WAS ON THE XLUNG KIT 230 AFTERWARDS WITH A BLOOD FLOW OF 3 L/MIN. THERE WAS A DECLINE IN OXYGENATION LEADING TO THE NEED TO INCREASE BLOOD FLOW TO 6 L/MIN AND 100% FRACTION OF INSPIRED OXYGEN (FIO2) INCLUDING 20 PPM INHALED NITRIC OXIDE, WHICH RESULTED IN SATISFACTORY OXYGENATION. UPON FOLLOW-UP, IT WAS REPORTED THAT AFTER INCREASING THE BLOOD FLOW TO 6 L/MIN WITH 100% FIO2, THE POST-OXYGENATOR ARTERIAL OXYGEN VALUES WERE SUFFICIENT AT 187 MMHG TO 217 MMHG. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.