XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED, ON APRIL 27TH, 2025, FROM 1:30 P.M. TO 10:00 P.M., DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE DEVICE FUNCTIONED PROPERLY ON A PATIENT UNDER MEDICALLY INDUCED COMA. AROUND 10:00 P.M., A MALFUNCTION OCCURRED ACCOMPANIED BY SEVERAL ALERT MESSAGES: CLOT DETECTED IN THE CIRCUIT, AIR BUBBLE DETECTED, AND PUMP HEAD STOPPED. A DE-BUBBLING PROCEDURE WAS INITIATED BY THE USERS, BUT THE SAME ERROR MESSAGES REAPPEARED. ANTICOAGULATION PROTOCOL IN PLACE: A TOTAL OF 15,000 IU OF SODIUM HEPARIN WAS USED TO FLUSH THE CIRCUIT, AND THE PATIENT WAS RECEIVING A CONTINUOUS INFUSION OF HEPARIN AT 20,000 IU/DAY AS PART OF THE ANTICOAGULATION PROTOCOL. THE PATIENT EXPIRED. THE FACILITY MENTIONED THAT THERE IS NO DIRECT CAUSAL LINK ESTABLISHED, ALTHOUGH THE INTENSIVE CARE UNIT TEAM INDICATED THAT THE EVENT CONTRIBUTED TO THE OUTCOME, AS THE PATIENT EXPERIENCED HEMOLYSIS DUE TO THE EVENT. THE FACILITY WAS NOT ABLE TO PROVIDE KIT INFORMATION. THE FACILITY DID NOT MENTION ANY PART OF THE CIRCUIT THAT COULD HAVE LED TO THE EVENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION. UPON FOLLOW-UP FROM THE XENIOS COMPLAINT MANAGER, IT WAS REPORTED THIS PATIENT WAS PLACED ON ECMO SUPPORT ON AN UNDETERMINED DATE FOR AN UNREPORTED CAUSE. THE XLUNG KIT 230 AND CONSOLE WERE EXCHANGED FOLLOWING THIS EVENT. THE PATIENT EXPIRED DURING ECMO SUPPORT THE FOLLOWING DAY DUE TO AN UNREPORTED CAUSE. IT WAS CONFIRMED THAT THE PATIENT¿S DEATH WAS NOT A DIRECT RESULT OF A MALFUNCTION OR DEFICIENCY OF ANY XENIOS PRODUCT(S) OR DEVICE(S).

Additional Manufacturer Narrative

A REVIEW OF THE BATCH DOCUMENTATION OF ALL BATCH NUMBERS OF THE XLUNG KIT 230 RECEIVED BY THE FACILITY REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. ADDITIONALLY, NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THESE BATCH NUMBERS. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE BATCH IS UNKNOWN AND NO RETENTION SAMPLE ANALYSIS WAS PERFORMED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, THE RECORD WILL BE UPDATED ACCORDINGLY.

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 (B)(6) 2025, FROM 1:30 P.M. TO 10:00 P.M., THE DEVICE FUNCTIONED PROPERLY ON A PATIENT UNDER MEDICALLY INDUCED COMA. AROUND 10:00 P.M., A MALFUNCTION OCCURRED ACCOMPANIED BY SEVERAL ALERT MESSAGES: CLOT DETECTED IN THE CIRCUIT, AIR BUBBLE DETECTED, AND PUMP HEAD STOPPED. A DE-BUBBLING PROCEDURE WAS INITIATED BY THE USERS, BUT THE SAME ERROR MESSAGES REAPPEARED. ANTICOAGULATION PROTOCOL IN PLACE: A TOTAL OF (B)(4) IU OF SODIUM HEPARIN WAS USED TO FLUSH THE CIRCUIT, AND THE PATIENT WAS RECEIVING A CONTINUOUS INFUSION OF HEPARIN AT (B)(4) IU/DAY AS PART OF THE ANTICOAGULATION PROTOCOL. THE PATIENT EXPIRED. THE FACILITY MENTIONED THAT THERE IS NO DIRECT CAUSAL LINK ESTABLISHED, ALTHOUGH THE INTENSIVE CARE UNIT TEAM INDICATED THAT THE EVENT CONTRIBUTED TO THE OUTCOME, AS THE PATIENT EXPERIENCED HEMOLYSIS DUE TO THE EVENT. THE FACILITY WAS NOT ABLE TO PROVIDE KIT INFORMATION. THE FACILITY DID NOT MENTION ANY PART OF THE CIRCUIT THAT COULD HAVE LED TO THE EVENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION. UPON FOLLOW-UP FROM THE XENIOS COMPLAINT MANAGER, IT WAS REPORTED THIS PATIENT WAS PLACED ON ECMO SUPPORT ON AN UNDETERMINED DATE FOR AN UNREPORTED CAUSE. THE XLUNG KIT 230 AND CONSOLE WERE EXCHANGED FOLLOWING THIS EVENT. THE PATIENT EXPIRED DURING ECMO SUPPORT THE FOLLOWING DAY DUE TO AN UNREPORTED CAUSE. IT WAS CONFIRMED THAT THE PATIENT¿S DEATH WAS NOT A DIRECT RESULT OF A MALFUNCTION OR DEFICIENCY OF ANY XENIOS PRODUCT(S) OR DEVICE(S).