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 FLUID WAS FLOWING THROUGH THE SWEEP GAS LINE DURING PRIMING. PROVIDED VIDEO EVIDENCE SHOWED FLUID IN THE SWEEP GAS TUBE THAT ORIGINATED FROM THE OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT FLUID WAS FLOWING THROUGH THE SWEEP GAS LINE DURING PRIMING. PROVIDED VIDEO EVIDENCE SHOWED FLUID IN THE SWEEP GAS TUBE THAT ORIGINATED FROM THE OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9, H6. PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION. THE LEAK COULD BE REPRODUCED DURING INVESTIGATION. IT WAS REPORTED THAT LIQUID LEAKED TO THE GAS CHAMBER AT THE TOP OF THE OXYGENATOR. THE OXYGENATOR WAS CUT VERTICALLY AT THE LEAK LOCATION AND HORIZONTALLY AT THE TOP TO EXAMINE THE POTTING OF THE GAS EXCHANGER. HOWEVER, NO DEFECT WAS FOUND AT THE POTTING. THE MOST PROBABLE ROOT CAUSE MIGHT BE MECHANICAL DAMAGE TO THE CAPILLARIES. ALTHOUGH OUR OXYGENATORS ARE 100% LEAK TESTED, IN A FEW CASES LEAKAGE MAY OCCUR DUE TO ADVERSE ENVIRONMENTAL CONDITIONS OR MECHANICAL STRESS DURING TRANSPORTATION.