XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED A BLOOD LEAK COMING FROM AN IPS SENSOR PORT. THE USER CUT OUT THE SENSOR AND USED A CONNECTING DEVICE TO JOIN THE CUT END OF THE TUBES BACK TOGETHER. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NO 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 BLOOD LEAK COMING FROM AN INTEGRATED PRESSURE SENSOR PORT. PRESSURE VALUES WERE STILL BEING DISPLAYED ON THE CONSOLE. DUE TO THE LEAK, THE USER CUT OUT THE SENSOR AND USED A CONNECTING DEVICE TO JOIN THE CUT END OF THE TUBES BACK TOGETHER. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50 ML. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, H6. PLANT INVESTIGATION: NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER, AND A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO NON-CONFORMITY. THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION, AND A DEFINITIVE CAUSE COULD NOT BE CONFIRMED. POSSIBLE CAUSES OF THE LEAK INCLUDE DEFECTIVE GLUING OF THE INTEGRATED PRESSURE SENSOR (IPS) OR DAMAGE OF THE TUBE DURING MANUFACTURING PROCESS, A DEFECT IN THE TUBE NEAR OR UNDERNEATH THE SENSOR CASING AND/OR OVERBENDING OF THE TUBE CLOSE TO THE IPS. AS A PHYSICAL EVALUATION COULD NOT BE CARRIED OUT, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, THE RECORD WILL BE UPDATED ACCORDINGLY.