XLUNG KIT (USA)

Description of Event or Problem

A USER FACILITY REPORTED A LOUD NOISE HEARD DURING SUPPORT COMING FROM THE PUMP HEAD. A NURSE NOTIFIED THE CLINICAL SPECIALIST OF THE NOVALUNG MAKING A LOUD NOISE. THE NURSE RECORDED THE EVENT. THE PATIENT WAS ON SUPPORT FOR APPROXIMATELY 5 DAYS WHILE NO COMPLICATIONS WERE ENCOUNTERED, LDH LEVELS WERE WITHIN NORMAL RANGE AND CONSISTENT THROUGHOUT SUPPORT. THE PATIENT WAS SIGNIFICANTLY ILL WHILE EXHIBITING MULTI-ORGAN FAILURE PRIOR TO INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT AS A LAST EFFORT TO TRY AND TURN THEIR CONDITION AROUND. THE PATIENT ULTIMATELY SUCCUMBED TO THEIR ILLNESS SECONDARY TO A SIGNIFICANTLY ISCHEMIC BOWEL. SUPPORT WAS WITHDRAWN WHEN EFFORTS BECAME FUTILE. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

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 A LOUD NOISE HEARD DURING SUPPORT COMING FROM THE PUMP HEAD. A NURSE NOTIFIED THE CLINICAL SPECIALIST OF THE NOVALUNG MAKING A LOUD NOISE. THE NURSE RECORDED THE EVENT. THE PATIENT WAS ON SUPPORT FOR APPROXIMATELY 5 DAYS WHILE NO COMPLICATIONS WERE ENCOUNTERED, LDH LEVELS WERE WITHIN NORMAL RANGE AND CONSISTENT THROUGHOUT SUPPORT. THE PATIENT WAS SIGNIFICANTLY ILL WHILE EXHIBITING MULTI-ORGAN FAILURE PRIOR TO INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT AS A LAST EFFORT TO TRY AND TURN THEIR CONDITION AROUND. THE PATIENT ULTIMATELY SUCCUMBED TO THEIR ILLNESS SECONDARY TO A SIGNIFICANTLY ISCHEMIC BOWEL. SUPPORT WAS WITHDRAWN WHEN EFFORTS BECAME FUTILE. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

CLINICAL REVIEW: UPON FOLLOW-UP WITH THE LOCAL CLINICAL SUPPORT SPECIALIST, IT WAS REPORTED THIS PATIENT WAS INITIALLY PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT ON 11/MAY/2026 DUE TO IMPENDING MULTI-ORGAN FAILURE AND ISCHEMIC BOWEL. UPON INITIATION OF SUPPORT, A LOUD NOISE AT THE PUMP HEAD OCCURRED; HOWEVER, IT WAS CONFIRMED BY A USER FACILITY PERFUSIONIST THAT THE NOISE WAS NORMAL CONSIDERING THE PATIENT¿S CRITICAL CONDITION. ADDITIONALLY, THE PATIENT¿S CONDITION WAS TENUOUS, AND IT WAS DECIDED NOT TO SWITCH OUT ANY COMPONENT OF THE PATIENT CIRCUIT AS THE PATIENT DID NOT TOLERATE LOWER BLOOD FLOWS FOR ANY EXTENDED PERIOD OF TIME. THE DECISION WAS MADE TO WITHDRAW SUPPORT ON 16/MAY/2026 AFTER IT WAS DETERMINED THAT FURTHER LIFE-SAVING MEASURES WERE FUTILE AND THE PATIENT EXPIRED SHORTLY AFTER THE DISCONTINUATION OF ECMO. IT WAS REPORTED THAT THE PATIENT¿S DEATH WAS ATTRIBUTED TO HER CRITICAL CONDITION WITH NO INDICATION OF A CAUSAL OR CONTRIBUTING DEFICIENCY OR MALFUNCTION OF ANY XENIOS PRODUCT(S) OR DEVICE(S). THE SOURCE OF THE NOISE REMAINED UNKNOWN BUT DID NOT AFFECT ECMO SUPPORT OR THE PATIENT¿S SUBSEQUENT OUTCOME. A TEMPORAL RELATIONSHIP DOES NOT EXIST BETWEEN ECMO SUPPORT UTILIZING THE XLUNG KIT (USA) AND THE PATIENT¿S DEATH AS THE PATIENT WAS REMOVED FROM SUPPORT PRIOR TO DEATH. THE CAUSE OF THIS PATIENT¿S DEATH WAS ATTRIBUTED TO THEIR CRITICAL CONDITION WITH NO INDICATION OF A CAUSAL OR CONTRIBUTING MALFUNCTION OR DEFICIENCY OR ANY XENIOS PRODUCT(S) OR DEVICE(S). IT CAN BE CONCLUDED THAT THE PATIENT¿S DEATH WAS NOT THE RESULT OF A DEFICIENCY OR MALFUNCTION OF ANY XENIOS PRODUCT(S) OR DEVICE(S) AND WAS PREDICATED SOLELY ON THE PATIENT¿S CRITICAL CONDITION. THEREFORE, THE XLUNG KIT (USA) CAN BE EXCLUDED AS THE ROOT CAUSE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENT. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.