XLUNG KIT (USA)

Additional Manufacturer Narrative

PLANT INVESTIGATION (UPDATED FROM MANUFACTURER): NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. A REVIEW OF COMPLAINTS FROM THIS BATCH NUMBER DOES NOT INVOLVE THE FAILURE PATTERN AT HAND. THE SAMPLE WAS RECEIVED WITHOUT PACKAGING. THE PIGTAIL EXTENSION WAS RETURNED, AND DAMAGE WAS NOTED ON THE CONNECTOR. NO OTHER DAMAGE OR IRREGULARITIES WERE FOUND. A CRACK IN THE LUER-LOCK NEGATIVE ADAPTER CAN BE SEEN ON THE PROVIDED PHOTO. THE COMPONENT IS A PURCHASED PART. DUE TO PREVIOUS COMPLAINTS A TOOL OPTIMIZATION WAS CARRIED ON THIS PART IN JULY 2021. CRACKS IN THE LUER ADAPTER COULD BE DUE TO A PROBLEM IN THE INJECTION MOLDING PROCESS.

Description of Event or Problem

A USER FACILITY REPORTED THAT THEY HAD PREVIOUSLY EXPERIENCED A CRACKED, (OUTLET SIDE) OXYGENATOR PIGTAIL WITH BLOOD LEAK THAT REQUIRED CHANGE OUT. PER THE CUSTOMER, IT WAS NOTED ON (B)(6) 2025 THAT BLOOD WAS LEAKING FROM THE PIGTAIL REQUIRING CLAMPING AND PIGTAIL EXCHANGE. THE CUSTOMER EXPLAINED THAT THE PATIENT WAS RECEIVING PROPOFOL (ADMINISTERED DIRECTLY TO THE PATIENT AND NOT THROUGH THE CIRCUIT PIGTAIL), HOWEVER, THE USERS NOTED WHITE DEPOSITS BUILDING UP WITHIN THE PIGTAIL PRIOR TO CRACKING. AT 25 HOURS INTO SUPPORT, BLOOD WAS FOUND TO BE LEAKING FROM THE CRACK REQUIRING THE PATIENT TO BE TAKEN OFF OF SUPPORT TEMPORARILY TO CHANGE OUT THE PIGTAIL. THE PATIENT WAS UNAFFECTED AND REMAINED ON SUPPORT WITH THIS CIRCUIT AT THE TIME OF THE INITIAL REPORT. THE COMPLAINT SAMPLE WAS RETURNED FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. A REVIEW OF COMPLAINTS FROM THIS BATCH NUMBER DO NOT INVOLVE THE FAILURE PATTERN AT HAND. THE SAMPLE WAS RECEIVED WITHOUT PACKAGING. THE PIGTAIL EXTENSION WAS RETURNED AND DAMAGE WAS NOTED ON THE CONNECTOR. NO OTHER DAMAGE OR IRREGULARITIES WERE FOUND. CRACKS IN THE LUER ADAPTER COULD BE DUE TO A PROBLEM IN THE INJECTION MOLDING PROCESS. AS THE ISSUE WAS FOUND TO BE FROM MOLDING PROCESS, THE PROBABLE CAUSE CODE INCLUDES MATERIAL AND/OR CHEMICAL PROBLEM IDENTIFIED. AS THE ISSUE CAUSED A LEAK, THE PROBABLE CAUSE WAS TRACED TO COMPONENT FAILURE.

Description of Event or Problem

A USER FACILITY REPORTED THAT THEY HAD PREVIOUSLY EXPERIENCED A CRACKED, (OUTLET SIDE) OXYGENATOR PIGTAIL WITH BLOOD LEAK THAT REQUIRED CHANGE OUT. PER THE CUSTOMER, IT WAS NOTED ON (B)(6) 2025 THAT BLOOD WAS LEAKING FROM THE PIGTAIL REQUIRING CLAMPING AND PIGTAIL EXCHANGE. THE CUSTOMER EXPLAINED THAT THE PATIENT WAS RECEIVING PROPOFOL (ADMINISTERED DIRECTLY TO THE PATIENT AND NOT THROUGH THE CIRCUIT PIGTAIL), HOWEVER, THE USERS NOTED WHITE DEPOSITS BUILDING UP WITHIN THE PIGTAIL PRIOR TO CRACKING. AT 25 HOURS INTO SUPPORT, BLOOD WAS FOUND TO BE LEAKING FROM THE CRACK REQUIRING THE PATIENT TO BE TAKEN OFF OF SUPPORT TEMPORARILY TO CHANGE OUT THE PIGTAIL. PATIENT WAS UNAFFECTED AND REMAINED ON SUPPORT WITH THIS CIRCUIT AT THE TIME OF THE INITIAL REPORT. THE COMPLAINT SAMPLE WAS RETURNED FOR PRODUCT EVALUATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT THEY HAD PREVIOUSLY EXPERIENCED A CRACKED, (OUTLET SIDE) OXYGENATOR PIGTAIL WITH BLOOD LEAK THAT REQUIRED CHANGE OUT. PER THE CUSTOMER, IT WAS NOTED ON (B)(6) 2025 THAT BLOOD WAS LEAKING FROM THE PIGTAIL REQUIRING CLAMPING AND PIGTAIL EXCHANGE. CUSTOMER EXPLAINED THAT THE PATIENT WAS RECEIVING PROPOFOL (ADMINISTERED DIRECTLY TO THE PATIENT AND NOT THROUGH THE CIRCUIT PIGTAIL), HOWEVER, THE USERS NOTED WHITE DEPOSITS BUILDING UP WITHIN THE PIGTAIL PRIOR TO CRACKING. AT 25 HOURS INTO THE RUN, BLOOD WAS FOUND TO BE LEAKING FROM THE CRACK REQUIRING THE PATIENT TO BE TAKEN OFF OF SUPPORT TEMPORARILY TO CHANGE OUT THE PIGTAIL. PATIENT WAS UNAFFECTED AND REMAINS ON SUPPORT WITH THIS CIRCUIT AT THE TIME OF THIS REPORT. THE COMPLAINT SAMPLE IS AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.