XLUNG KIT (USA)

Additional Manufacturer Narrative

PLANT INVESTIGATION: MANUFACTURING DOCUMENTATION OF THIS PRODUCT WAS WITHOUT DEVIATIONS CONCERNING THE FAILURE PATTERN AT HAND. TWO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. PHOTOS WERE PROVIDED SHOWING THAT THE VENOUS VENTING PORT AT THE TOP OF THE OXYGENATOR WAS BROKEN. INVESTIGATION OF THE RETAINED SAMPLE OF THIS BATCH REVEALED THAT THE FIXING TAPE FOR SECURING AND STABILIZING THE OXYGENATOR FOR TRANSPORT WAS NOT CORRECTLY ATTACHED, AND THE OXYGENATOR SLIPPED SLIGHTLY OUT OF ITS HOLDING TRAY. ADDITIONALLY, FLUID RESIDUE WAS FOUND IN THE OXYGENATOR UPON PRODUCT INVESTIGATION WHICH SHOWED THE BREAKAGE WAS DISCOVERED EITHER DURING OR AFTER PRIMING OF THE CIRCUIT. THE PROBABLE CAUSE FOR THE DAMAGED OXYGENATOR WAS AN INADEQUATE SECURING TO THE PACKAGING AND THE PORT WAS DAMAGED DURING TRANSPORT.

Description of Event or Problem

A USER FACILITY REPORTED A BROKEN VENOUS SAMPLING PORT ON THE XLUNG KIT (USA) OXYGENATOR UPON OPENING PACKAGE. THE USER OPENED AN XLUNG KIT IN PREPARATION FOR AN EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE USER DISCOVERED THE VENOUS SAMPLING PORT OF THE OXYGENATOR WAS BROKEN DURING PRIMING OF THE KIT. THE FACILITY DISCARDED THE KIT AND OPENED A SECOND XLUNG KIT. THE USER DISCOVERED THE SAME PROBLEM WITH A BROKEN VENOUS SAMPLING PORT IN THE SECOND KIT WHICH WAS NOT PRIMED. UPON OPENING A THIRD KIT, ALL COMPONENTS WERE INTACT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RETURNED TO XENIOS FOR PRODUCT INVESTIGATION.