XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED A TEMPERATURE PORT BLOOD LEAKAGE THAT OCCURRED AFTER 4 HOURS AND 10 MINUTES FROM EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT START. THE LEAK WAS DETERMINED TO BE MINOR AND THE CLINICAL ASSESSMENT OF THE PATIENT'S CONDITION DID NOT WARRANT REPLACING THE OXYGENATOR. STERILE GAUZE WAS USED TO PLUG THE LEAK. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

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 A TEMPERATURE PORT BLOOD LEAKAGE THAT OCCURRED AFTER 4 HOURS AND 10 MINUTES FROM EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT START. THE LEAK WAS DETERMINED TO BE MINOR AND THE CLINICAL ASSESSMENT OF THE PATIENT'S CONDITION DID NOT WARRANT REPLACING THE OXYGENATOR. STERILE GAUZE WAS USED TO PLUG THE LEAK. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO RESULTING SERIOUS INJURY OR ADVERSE EVENT AS THE BLOOD LOSS WAS DETERMINED TO BE LESS THAN 50 ML.

Additional Manufacturer Narrative

D4 PLANT INVESTIGATION: UPON BATCH REVIEW, NO QUALITY EVENTS REFER TO THE DESCRIBED FAILURE PATTERN IN THIS COMPLAINT. TREND ANALYSIS SHOWED ONE OTHER COMPLAINT THAT WAS REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. ALL OXYGENATORS ARE TESTED FOR LEAKAGES DURING PROCESS CONTROLS. DUE TO 100% LEAK TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. BECAUSE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A DEFINITIVE CAUSE OF THE DESCRIBED LEAK COULD NOT BE DETERMINED. IT IS POSSIBLE THAT CRACKS MAY SUBSEQUENTLY OCCUR IN THE TEMPERATURE PORT DURING TRANSPORT OR HANDLING.