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 THERE WERE SEVERAL HAIRLINE CRACKS IN THE OXYGENATOR AT THE BOTTOM SIDE THAT LEAKED WITH PRIMING SOLUTION. CRACKS ARE SAID TO BE AT THE CONJUNCTION OF THE CYLINDRIC PART AND THE LID OF THE OUTER HOUSING. THERE WAS NO PATIENT INVOLVED. THE COMPLAINT SAMPLE WAS AVAILABLE PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D3, D4, D9, G1, H3, H6. PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING MANUFACTURING PROCESS. NO OTHER COMPLAINTS INVOLVING THIS BATCH NUMBER FOLLOW THE SAME FAILURE PATTERN AT HAND. ACCORDING TO LOCAL AUTHORITY, THE SAMPLE WAS NO LONGER AVAILABLE AND NOT RETURNED TO THE MANUFACTURER FOR PRODUCT INVESTIGATION. PROVIDED PHOTOGRAPHS SHOW FLUID DRIPPING FROM THE GAS PORT AND SOME DRIED PRIMING FLUID ON THE EDGE OF THE OXYGENATOR BASE. AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION, AND BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE LEAK COULD NOT BE DETERMINED.

Description of Event or Problem

A USER FACILITY REPORTED THAT THERE WERE SEVERAL HAIRLINE CRACKS IN THE OXYGENATOR AT THE BOTTOM SIDE THAT LEAKED WITH PRIMING SOLUTION. CRACKS WERE SAID TO BE AT THE CONJUNCTION OF THE CYLINDRIC PART AND THE LID OF THE OUTER HOUSING. THERE WAS NO PATIENT INVOLVED. THE COMPLAINT SAMPLE WAS INITIALLY AVAILABLE PRODUCT EVALUATION; HOWEVER, THE PRODUCT WAS NOT RETURNED BY THE USER FACILITY.