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 SUPPORT WAS WITHDRAWN WHEN EFFORTS BECAME FUTILE.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.