XLUNG KIT 230

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 A RECIRCULATION PORT HAD BLOOD LEAKAGE FOLLOWING 10 HOURS AFTER EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT START. THE PATIENT LOST APPROXIMATELY 50 ML OF BLOOD. PATIENT REMAINED ON ECMO SUPPORT WITH THE SAME XLUNG KIT 230. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO RESULTING PATIENT INJURY. THE PATIENT WAS DISCONTINUED FROM ECMO SUPPORT AND TRANSFERRED TO THE GENERAL MEDICAL WARD. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT A RECIRCULATION PORT HAD BLOOD LEAKAGE FOLLOWING 10 HOURS AFTER EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT START. THE PATIENT LOST APPROXIMATELY 50 ML OF BLOOD. PATIENT REMAINED ON ECMO SUPPORT WITH THE SAME XLUNG KIT 230. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO RESULTING PATIENT INJURY. THE PATIENT WAS DISCONTINUED FROM ECMO SUPPORT AND TRANSFERRED TO THE GENERAL MEDICAL WARD. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D3, D4, G1 PLANT INVESTIGATION: NONCONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. ONE OTHER COMPLAINT FROM THE SAME BATCH NUMBER FOLLOWS THE SAME FAILURE PATTERN. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. PHOTOGRAPHS AND VIDEO EVIDENCE HAVE BEEN PROVIDED THAT SHOWED A BLOOD LEAK THAT ORIGINATED FROM THE RECIRCULATION PORT. WHITE RESIDUE CAN ALSO BE SEEN UNDER THE PORT ON THE OXYGENATOR HOUSING WHICH MAY HAVE BEEN CAUSED BY DRIED PRIMING FLUID. IT IS ASSUMED THAT THE LEAK WAS CAUSED BY MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT.