XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 PLANT INVESTIGATION: NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER, AND A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. NO PHOTOS WERE PROVIDED BY THE REPORTING FACILITY, AND THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. AS THE COMPLAINT SAMPLE COULD NOT BE EVALUATED, A DEFINITE CAUSE OF THE DESCRIBED PROBLEM COULD NOT BE DETERMINED. A POSSIBLE CAUSE IS A DEFECT AT THE PORT. THE LEAK MAY HAVE BEEN SUBSEQUENTLY CAUSED BY THE RELEASE OF MATERIAL STRESS, FOR EXAMPLE DURING HANDLING, E.G. TIGHTENING OF THE CONNECTION OR TRANSPORT. POTENTIAL ROOT CAUSES DURING PRODUCTION HAVE BEEN ANALYZED, AND MEASURES ARE BEING IMPLEMENTED.

Description of Event or Problem

A USER FACILITY REPORTED A BLOOD LEAKAGE AT THE THREADED CONNECTION OF THE TEMPERATURE PROBE DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT PLACEMENT. THERE WAS NO RESULTING PATIENT SERIOUS INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED 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.

Description of Event or Problem

A USER FACILITY REPORTED A BLOOD LEAKAGE AT THE THREADED CONNECTION OF THE TEMPERATURE PROBE DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT PLACEMENT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.