XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING THE ASSEMBLY AND PRIMING OF THE SUPPORT DEVICE, THE PRIMING SOLUTION LEAKED THROUGH THE PORTS FOR THE THERMAL UNIT. THE OXYGENATOR MEMBRANE WAS DAMAGED, SO THE CIRCUIT WAS THEREFORE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: IT WAS REPORTED THAT DURING PRIMING OF THE XLUNG KIT 230, PRIMING SOLUTION LEAKED OUT OF THE PORTS OF THE THERMAL UNIT. AS THE OXYGENATOR MEMBRANE WAS FOUND DAMAGED AND UNUSABLE, THE KIT WAS REPLACED. A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. A DEFINITE CAUSE OF THE LEAK COULD NOT BE DETERMINED. BASED ON THE DESCRIPTION, POSSIBLE CAUSES COULD BE A DEFECT IN THE HEAT EXCHANGER MAT OR A DEFECT IN POTTING OF THE HEAT EXCHANGE CYLINDER. ALTHOUGH OUR OXYGENATORS ARE 100% LEAK TESTED, IN A FEW CASES LEAKAGE MAY OCCUR DUE TO ADVERSE ENVIRONMENTAL CONDITIONS OR MECHANICAL STRESS.